Systematic Review: Impact of Topical Treatments on Arterial Leg Ulcers

This report presents a systematic review investigating the impact of topical treatments and wound dressings on the healing of arterial leg ulcers. The study employed a methodology involving a comprehensive search of databases like Science Direct, Cochrane Library, Google Scholar, and PubMed to identify relevant scholarly articles published between 2000 and 2021, with an exception for a 1991 clinical trial. The review aimed to assess the effects of various topical agents (ointments and creams) and wound dressings on healing rates and patient outcomes. The findings highlight a scarcity of conclusive data on the effectiveness of specific topical medications or dressings in influencing the overall recovery of arterial ulcerations, thereby emphasizing the need for further research to establish evidence-based treatment strategies. The review also includes an overview of the etiology, pathophysiology, and current clinical practices for managing arterial ulcers, discussing assessment methods, and providing a literature review of the topic. The study underlines the significance of arterial ulcer management, which includes improving blood flow and managing the wound, in order to prevent complications like infection and amputation.

PUBLIC
Abstract
Background
According to estimates, up to 1% of persons in high-income economies will get a leg ulceration
at a certain point in life. A preponderance of ulcerations is caused by circulatory abnormalities;
venous ulceration (which account for about 70% of lesions) and arterial ulcers (which account
for the remaining 30% of ulcers) are caused by insufficient blood flow to the legs (around 22
percent of ulcers). Therapies for arterial leg ulcers focuses on improving arterial blood flow, such
as by removing arterial obstructions (either pharmaceutically or surgically). Such arterial
ulceration may recover if the vascular circulation is reinstated and wound management
procedures are followed. Dressings and topical treatments are an important aspect of wound
management for arterial ulcers, however there are a lot of them, and it's unknown how they affect
ulcer treatment.
Objectives
To investigate as to if topical treatments and wound dressings have an effect on the recovery of
artery ulceration. And assess the rates of healing and the consequences. A comparative of wound
dressings and topical treatments accessible.
Research Objectives
Is there an impact of using Topical agents (ointments and creams) and wound dressings used to
treat arterial leg ulcers healing?
Methodology
Science Direct, Cochrane Library, Google Scholar and PubMed were used to conduct a
systematic review on pertinent scholarly resources on descriptive study. Six (6) investigation
articles involving cross-sectional and descriptive methodologies was methodically chosen and
assessed through diverse resources. Thereby, publications on arterial leg ulcers topical agent and
dressing wound management were retrieved from 2000 to 2021 were included, whilst also
resources older than 2009 were excluded.

PUBLIC
Nevertheless, a clinical trial from 1991 was chosen as it was in line with the inclusive criteria,
and some other publications which did not rely upon that research problem were excluded. Size
of sample was not limited hence individuals represented with arterial leg ulcer off all ages and
sex were included in the study.
Results
When the ketanserin subgroup was contrasted to the control cohort, lesion recovery was shown
to be faster in the ketanserin cluster. Another experiment stated that no participants encountered
adverse effects (complications) during follow-up (six weeks, poor confidence information). Yet
another study examined topical administration of blood derived concentrated growth factor
(CGF) versus conventional dressings (polyurethane films or foaming), which were either
administered weekly over 6 weeks by 61 people having non-healing ulceration.
Conclusion
The fraction of information available to assess whether the topical medication or dressing used
influences overall recovery of arterial ulcerations is inadequate.
Key words: Arterial leg ulcer, Wound healing, topical agents, dressings, creams, ointments

PUBLIC
Chapter One
1.0 Introduction
Nursing centers upon promoting the healthcare initiatives which every patient life or pursues.
Within such perspective, management strives to avoid illnesses & encourage disease readaptation
processes across the life cycle, as well as to fulfill the minimum human demands and achieve
maximum autonomy in everyday tasks. As a result, nursing care assists individuals in managing
community health resources while also emphasizing the need of playing a central function
throughout the unit (Fonseca et al., 2012; As a consequence of the growth of human longevity
and also the associated frequency of chronic conditions including such leg ulcers, healthcare
patients' demands are becoming more exacting and complicated (Van, Grypdonck and Defloor,
2009). The management of chronic wounds represent a serious societal concern due to its scope,
intricacy, & expense. Most leg ulcers are believed to affect 8–10 million people globally,
whereas pressure sores affect 7–8 million (Fonseca et al., 2015; Singh et al., 2003).
Limb ulcers are a frequent chronic ailment which can irritating and has a detrimental effect on
individual 's wellbeing. According to a comprehensive study, 1.1 percent to 0.12 percent of
overall adult populace is affected by lower-leg ulceration (Graham 2003). Venous insufficiency
(impaired blood circulation in the venous), vascular illness, and diabetes are the most common
causes of ulceration. Despite venous illness causes overall preponderance of leg ulcers, a
considerable proportion of persons with ulcerations (approximately 22 percent) have artery
insuFiciency. Heterogeneous aetiologies account for over 15% of leg ulcers, such as those
caused by arterial and venous illness or diabetic combined arterial pathology (Fonseca et al.,
2015; Broderick, Pagnamenta, and Forster, 2020). A restriction of blood flow to the skin causes
arterial leg ulcers. A constriction of the arteries in the legs could perhaps represent the reason
(atherosclerosis). It's critical to distinguish amongst arterial and venous leg ulcers because
compression treatments, which is the basis of management for venous leg ulcers, might cause
skin necrosis (or possibly amputation) when used on arterial leg ulceration (O'Meara 2012 ;
Fonseca et al., 2015)

PUBLIC
A medical history is used to diagnose arterial insufficiency, also known as peripheral arterial
disease (PAD). The more frequent complication is discomfort, that might emerge while moving
and exercising. Periodic claudication develops when cramping discomfort with in leg comes
following activity but disappears once the limb is rested. Such complaints may worsen to the
point where the individual is in discomfort particularly while they are at repose (Fonseca et al.,
2015; Broderick, Pagnamenta, and Forster, 2020).
Diagnostics are frequently performed to determine the existence or lack of vascular disease in
order to measure what significant blood circulation is present in the leg. The ankle brachial index
is usually the initial test (ABPI, ABI). If the ABI ratio is less than 0.7, compression intervention
is not recommended, and the patient would be directed to a vascular expert that would request
supplementary testing, including either duplex ultrasonography and arteriography (Grey 2006).
The ABI criterion is normally around 0.6 and 0.7, while there is significant heterogeneity in the
literary works. Diagnosing PAD in persons having diabetes is difficult since neuropathic
conditions may hide symptoms and non-compressible arteries could provide fallacious ABI
results (Brownrigg 2016).
The cornerstone of treating arterial insufficiency would be to enhance overall blood flow, hence
surgical to circumvent or eliminate the obstruction is sometimes necessary. Owing to individual
desire, age, or overall health, and according to diffused distal arterial disease, in which the
arteries to be repaired are extremely tiny, that might not be achievable for certain individuals
(Grey, Harding and Enoch, 2006; Hedayati et al., 2015). Wound healing, exercising to enhance
blood circulation to the leg, pharmacological treatments, and physical therapy including such
hyperbaric oxygen are all non-surgical possibilities (Grey, Harding and Enoch, 2006; Hedayati et
al., 2015).
There are indications suggesting managing chronic wounds like leg ulcers puts a significant
psychological strain upon health professionals, particularly whenever the lesions do not recover
(Morgan and Moffatt, 2008; Posnett et al, 2009). Regrettably, such cost has rarely been
adequately investigated, with the exception of a universal acknowledgement of leg ulcer
treatment have an effect on individual patients, health care systems, and society as a whole.
There was also conclusive evidence indicating leg ulcer therapy has shifted from patient-centered

PUBLIC
to task-oriented (Persoon et al, 2004; Parkinson, 2006; Morgan and Moffatt, 2008).
Notwithstanding, wound management throughout general and leg ulcer treatment in particular
remain among of the highest prevalent referrals to community nursing (Rubi et al, 2003;
Eleftheriadou et al, 2019).
1.1 Study Justification
With the increasing burden of Leg ulcer management among healthcare individuals worldwide,
contemporary treatment methods are available in wound management, there is little to poor
literature available in the scientific community, despite the fact that a variety of dressings and
topical treatments are available, there is presently no evidence supporting their impact on the
pace of recovery in arterial ulcers.
1.2 Aim
The main objective of this research is to systematically review on comparison of dressing and
topic agents in the wound healing of arterial leg ulcer.
1.3 Research Objectives
1. Critical evaluation of existing literature on the available dressing and topical agents used in
wound healing
2. To evaluate topical treatments and wound healing in terms of recovery speeds and patient-
centered consequences.
3. Appraisal of the effective dressing and topical agents used in wound healing of arterial leg
ulcer
1.4 Research question
Is there an impact of using Topical agents (ointments and creams) and wound dressings used to
treat arterial leg ulcers healing?

PUBLIC
1.5 Significance of the study
Atherosclerotic ulceration with in lower limbs may lead to major consequences such as
infections, gangrene, resection, and fatality. It is critical to minimize arterial ulcers as well as
thus address its fundamental circulation flow deficit as soon as possible. Improved circulation,
cautious wound debridement, and pain management are all nursing aims. To prevent an ulcer
from infection, manage exudate, improve autolytic debridement, minimize pain, and promote a
supportive therapeutic milieu, employ occlusive treatments. Dressings and topical treatments are
an important aspect of wound management for arterial ulcers, however there are a lot of them,
and it's unknown how they affect healing process. With the paucity of literature emphasizing the
best therapeutic management of atrial leg ulcers, this systematic review would analyze existing
dressing and topical agents utilized in managing wounds. On the contrary novel clinical trials
accessing efficacy and usage of topical agents and dressing would also be evaluated which could
provide key insights in drawing conclusive suggestions on the effective management strategies
that could be employed in the clinical setting.

PUBLIC
Chapter Two
Literature Review
1.0 Introduction
This section will offer a comprehensive overview of the aetiology, pathophysiology, and current
dressings and topical medicines used in clinical practice for arterial ulcers. There will also be a
glimpse at the prevalence of the disease, the influence of promoting health in terms of
prevention, and the consequences of poor ulcer care on prognosis. Additional evidence would be
gathered through a study of existing medical literature that takes into account current nursing
procedures. Ultimately, the existing literature on the effectiveness of currently used treatment
approaches will be thoroughly examined.
1.1 Arterial leg ulcers and pathophysiology
A decreased arterial blood flow to the lower leg causes arterial ulceration. Atheromatous diseases
of both the large and medium arteries is the most prevalent cause. Diabetes, vasculitis,
thromboangiitis, pyoderma gangrenosum, sickle cell disease and thalassaemia are some of the
other conditions that may lead to atheroma development. Concurrent hypertension causes further
harm to the vascular system by damaging overall intimal layers of the artery. Tissue hypoxic and
tissue injury come from a decline in arterial blood flow. Tissue damage and ulcer development
may be exacerbated by thrombotic and atheroembolic events (Grey, Harding, and Enoch, 2006).
Ischemia of the dermis and underlying tissues may develop from arteriolar or arterial blockage,
which could progress to ulceration. Diabetes with macrovascular or microvascular diseases,
Atherosclerosisand/or vasculitis may all cause an ischemic leg, which can contribute to ulcers
(Sarkar and Ballantyne,2001).
The pathogenesis of an ischemic leg ulcer encompasses three pathways:
Extra - mural strangling (1) Mural hypertrophy or accumulation (2) Intramural blood flow
restriction
Extramural strangulation is caused by scar and radiodermatitis, which cause fibrotic bands
surrounding the arterioles, resulting in tiny but chronic ischemic ulcers. Mural thickening or

PUBLIC
intimal plaque accretion, as in atherosclerosis, could cause a reduction in blood circulation till
atherothrombosis, embolism, or a superimposed infection can cause full blockage, culminating in
ulceration. Changes throughout blood viscosity, platelet adhesiveness, and/or fibrinogenesis, as
in vasculitis, could obstruct the small vessels, actually results in leg ulceration.
There is frequently a significant comorbidity, and the precise etiology cannot always be
pinpointed. Owing to tissues ischemia and efflux of fibrin-like components, many acute types of
vasculitis, as well as certain subacute and chronic variants, are prone to induce leg ulcers (Sarkar
and Ballantyne,2001).
1.2 Assessment methods
There is presently insufficient significant literature which indicates on validated techniques built
particularly to acquire measurements on arterial ulcers (Beaumier et Al., 2021). Originally, the
vascular circulation to the legs were assessed manually examining the patient the palpitations on
the feet. Nevertheless, because of the mediocre predictive accuracy of such an assessment
(Moffatt 1995), objective evaluations particularly ones listed hereunder are now suggested. A
health history is taken and the blood flow to the limb is assessed to provide a prognosis (Taylor
1993). Pain is the most prevalent associated grievance. This discomfort might arise during
physical activity like walking. Intermittent claudication occurs when cramping discomfort in the
leg comes after activity and disappears when the limb is rested. This may proceed to the point
where the distance necessary to cause discomfort decreases, and the patient finally reports of
discomfort even while at rest. This is known as'rest ache.' This discomfort may not be felt by
those with neuropathy, such as diabetics. To establish the existence or absence of vascular
disease, laboratory testing are often performed. Ankle brachial pressure index (ABPI) and
doppler arterial waveform analysis are two examples.
1.3 Management of Arterial leg ulcers
Limb salvage and Wound healing remain the predominant goals of therapeutic interventions.
The goals of treatment are to address the root etiology of the ulcer and promote wound healing
utilizing the most up-to-date recommendations and wound management modalities (Suman

PUBLIC
2014). The initial stage in patient therapy is to take a complete clinical history, concentrating on
the length and extent of the ulcer as well as any concomitant lower extremity complaints.
Individuals with arterial diseases are more likely to be older and have major cardiovascular
comorbidities, thus a thorough assessment of their comorbidities and general health is critical
(Hedayati et Al., 2015).
Treatment algorithm (adapted from Valesci, 2012)
Management and treatment of arterial and venous extremities ulcers of the lower limbs requires
an integrated and multi-level strategy to ensure a satisfactory result. Ulcers should be
vascularized, devoid of necrosis and devitalized tissues, emancipate of infection, and maintained
moist to enable recovery. Optimal wound dressings drain fluid buildup while keeping the wound
moist, prevent bacterial invasion and/or propagation, remove dead zone, debride tissue
destruction, eliminate exposure of surrounding healthy tissue, and reduce discomfort during
treatment (Hedayati et Al., 2015). Various nations could utilize several methods for categorizing
dressings and topical treatments. There are also a range of topical treatments, such as cadexomer
iodine, honey, phenytoin, silver, and ketanserin, that try to modify the wound environment.
Topical antimicrobial and antibacterial treatments are often used in conjunction with dressings to
create an antimicrobial and antibacterial microenvironment (SIGN 2010). Hyperbaric oxygen,
vacuum therapy, and skin grafting are some of the other treatments for arterial ulcers (Broderick,
Pagnamenta and Forster, 2020; Forster and Pagnamenta, 2015).

PUBLIC
1.3.1 Dressings
The evolution of wounds dressings has progressed significantly in tandem with the increased acceptance
of wound healing philosophies. Wound coverings are now intended to encapsulate the wound and
promote wound healing (Vowden and Vowden, 2014). Because of their cheap cost and straightforward
production procedure, conventional dressings, also known as inert treatments (elastic bandage, cotton
pads, and gauze), are by far the largest extensively employed clinical dressings (Broughton et al., 2006).
Nevertheless, various drawbacks restrict their use, such as the difficulty of keeping the wound bed wet
and their proclivity for adherence with granulation tissues (Moore and Webster, 2013).
Due to its qualities that provide a humid microenvironment for healing process, advanced dressing could
be particularly viable choices (Moura et al., 2013; Heyer et al., 2013). Modern dressings have superior
biocompatibility, degradability, as well as moisture absorption as opposed to older dressings. Newer
dressings provide analgesic alleviation and ameliorate the hypoxic or anaerobic environments (Thu et
al., 2012; Hopper et al., 2012; Okuma et al., 2015). Hydrogels, hydrocolloids, foams, alginates and films
are the main often employed contemporary dressings in clinical settings.

PUBLIC
1.3.1.1 Hydrocolloids
A mixture of three hydrocolloids, such as sodium carboxymethylcellulose, pectin, and gelatin, is
used to coat such treatments. These are not suggested for use on infected ulcers due to their
occlusive nature. Because these generally only modestly absorbent, these may be employed in
weakly exudative ulceration or when autolytic debridement is desired. The creation of a thick,
pseudopurulent, and foul-smelling hydrogel, which might create the appearance of infections if
the physician is unaware of this potential, is one of the features of this kind of medicine that can

PUBLIC
restrict its usage. Foam products have now largely supplanted these treatments. (Dumville et al.
2015b; Sarkar and Ballantyne,2001)
1.3.1.2 cell based dressing
A live-cell composition including at minimum single stratum of living allogenic progenitors is
used to make cell-based dressing. Extracellular matix materials, independent (decellular) or in
conjunction with diverse cellular forms including such fibroblasts or keratinocytes, are used to
resemble natural skin. Skin replacements work as sterile tissue grafts that merge with native
tissue to promote cell migration, angiogenesis, and epithelialization in wounds (Jones et al.,
2013; Greaves et al., 2013).
1.3.1.3 Biological dressings
Whenever standard dressings perform poorly or are considered unsuitable, biologic dressings
may be utilized. Sheehan et al., (2006) found that using biological dressings in chronic lesions
which have ceased to recover at a suitable frequency of closures may result in a 55 percent
decrease in wound area in only four weeks. Such treatments could contain epidermal or dermal
components (Hedayati et al., 2015).
1.3.1.4 Polyurethane foams
Foam dressing generally composed of two layers: a hydrophobic exterior coating and a
hydrophilic and absorbent inner layer, which are formed up of a mix of polyurethanes, acrylates,
and other materials. Preparations are offered in both sticky & nonadhesive varieties. These are
semiocclusive and may be used on ulceration that are infected (Velasco, 2012).Foam treatments
insulate the lesion and keep it wet, as well as preventing injury to the wound when it is removed.
Such dressings might potentially be administered as a supplementary dressing for infected
wounds in combination using alginate or hydrogel dressing and a topical antibacterial treatment
(Davies et al., 2017) Furthermore, the presence of the anti-biofilm lichen metabolite usnic acids
in the polyaniline/polyurethane foam dressing suggested that the conducting polymer's
antibiofilm action had enhanced (dos Santos et al., 2018).

PUBLIC
1.3.1.5 Alginates
Sodium alginate is derived through brown seaweed and used to make alginates. These are
exceedingly absorbent and thus are utilized in ulcers with a lot of exudation. These reportedly
have hemostatic qualities, rendering them beneficial in anticoagulant-treated patients with
bleeding ulceration or following debridement. These must be trimmed to the form of the ulcer
since they may macerate the edge and, because they are not sticky, they often need a subsequent
treatment. SA treatments (O'Meara and Martyn-St James, 2013; Dumville et al., 2013c) comprise
fibrous materials generated from brown seaweed that may form a gel upon bonding to wounds
exudate. With in clinical, SA dressings are usually constructed of sheet fibers that may be cut
easily to fit the form of the wound. SA has likewise frequently applied to make hydrogels.
Because the SA dressings have good exudate absorption qualities, these may be utilized in both
infected as well as non-infected ulcers with a lot of effusion (Hess, 2000).
Conversely, a research found that an alginate hydrogel containing bioglass as well as
desferrioxamine improved diabetes cutaneous healing of wounds. The findings showed that
combining BG and DFO increased HUVEC movement and tubular development when opposed
to using both BG or DFO alone because BG and DFO may upregulate VEGF expression
synergistically (Kong et al., 2018).
1.3.1.6 Hydrofibers
Hydrofiber treatments are made with purified carboxymethylcellulose microfibers. This dressing
comprise the highest absorbent and are used on the most exudative ulcers. Because they are
neither sticky or impervious, they need a supplementary treatment.
1.3.1.7 Hydrogels
Hydrogels comprises polysaccharide and synthetic polymer formulations with a high water
content plus microcrystalline structures. These are available as gels or sheets and are just
somewhat absorbent. As a result, they're employed to treat dry ulcers and make autolytic
debridement easier. A secondary dressing is required for the hydrogel, that is the most often used
type. They're effective in lesions that have a lot of exudate but not a lot of blood. The hydrogel's

PUBLIC
breakdown velocity can be controlled, making it suitable for usage as a pharmaceutical
transporter and physiologically bioactive molecule (Gil et al., 2017). Silver nanoparticles (Ag
NPs) as well as zinc oxide nanoparticles (ZnO NPs) infused hydrogels, for instance, have long-
lasting antibacterial action (Li S. et al., 2018). A multimodal hydrogel treating diabetic foot
ulcers was subsequently developed as part of a research. The above hydrogel may be put on
diabetic foot ulcers to gather wound photographs through cellular devices and convert them into
RGB impulses for monitoring overall pH and glucose concentrations throughout significant
times (Zhu et al., 2019).
1.3.1.8 Film dressings
Porous, Adhesive and thin transparent polyurethane are used to make film dressings. The
dressing allows carbon dioxide, oxygen and water vapor from the wound to flow past, but germs
and fluids are kept separate. Film dressings also have autolytic debridement characteristics
(Thomas, 1990; Fletcher, 2003), making them appropriate for epithelializing wounds including
superficial injuries with minor exudates (Imran et al., 2004). The numerous kinds of dressings
discussed above each have their unique properties, therefore dressing selection must be
predicated on the wound's individual requirements.
1.3.2 Adjuvant Therapies
Numerous adjuvant therapy for arterial ulcers have a low degree of evidence, ranging between a couple
published studies to randomized research. Revascularization must be done if there is substantial arterial
disease. Adjuvant agents cannot substitute revascularization. Adjuvant agents may be effective
whenever revascularization is impractical or failed, or even whenever effective revascularization doesn't
quite lead to recovery. In addition to revascularization, adjuvant treatment may be beneficial in ensuring
healing. Most adjuvant medicines need further study to establish their optimum usage (timing, dose,
etc.)
1.3.2.1 Ultrasonography

PUBLIC
Ultrasonography could both have thermal and nonthermal consequences, such as increasing cell
membrane permeability and affecting the remodelling cycle (thermal) (nonthermal). While animal
experiments and published case indicate the usefulness of ultrasonography, the paucity of randomized
controlled trials (RCTs) and the wide range of settings employed in various research lead to incorrect a
prescription for its usage, especially in arterial ulcer (Cullum et al., 2001; Hess et Al , 2003).
1.3.2.2 Electrostimulation
Derived from animal research and case series, electrostimulation appears to be a potential adjuvant
treatment for arterial ulcers. To offer a clear suggestion, notwithstanding, adequate circumstances must
be defined and RCTs must be conducted (Kloth, 2005).
1.4 Nursing interventions
Knowing the detailed medical background (personal background, chronic diseases, present
condition of the client) and the ulcer's history is critical when it comes to nursing interventions in
the treatment and prevention of venous, arterial, or mixed leg ulcers (source, time, treatments
performed). After carefully assessing the wound's features (size, depth, exudate, wound bed, kind
of tissues, perilesional skin, discomfort) a choice must be taken in collaboration with the client to
set mutual objectives (Fonseca et Al., 2016).
Thereby, the therapies should include pain medication, wound preparedness, wound cleanup,
inventory control to be applied to the bed and perilesional epidermis, combined collection of the
sort of material for compressive treatment application as well as preparedness of a physical
exercise plan, ongoing client empowerment, referral to specialists in the event of allergic
reactions, the need for supplementary therapies, and/or non-effective treatment options.
Nursing interventions on wound management for ulcers are depicted on the below image

PUBLIC
Figure Fonseca 2016
Regarding a systematic nursing treatment that is successfully centered on the patient, it is primarily
necessary to mobilize abilities in order to develop efficient communication and interpersonal
relationships, which generate a warm atmosphere that is conducive to personalization of caring. This
personalisation allows for in-depth understanding of the patients' usual life patterns, social, financial,
and familial situations, as well as their views and predictions regarding their present status, and their
inclinations are linked to improved results. It has been discovered that in order to cope with the crisis
scenario caused by the sickness, it is necessary to stimulate adaptive strategies, with an emphasis on self
and commitment, which allowed them to see the new circumstance as a challenge rather than a danger.
The presence of social support, which is offered by a number of relevant persons, such as being in

PUBLIC
contact with others in comparable positions (self-support organizations) and with the nurse, was the
element most often described as being critical to the adjustment process. Training for health self-
management is critical for reducing co-morbidity because it minimizes preexisting health risks and
promotes physiological circumstances that are conducive to improved recovery. Monitoring and
controlling pain, providing comprehensive care, by employing a multidisciplinary teams strategy
enhanced patient satisfaction with the health plan, boosted treatment regimen compliance, and
improved patients' perceptions of quality of life. Another good factor related with the success of the
adopted therapies was ongoing as well as up-to-date instruction of nurses who care for people with leg
ulcers. The importance of implementing an adequate and timely therapy cannot be separated from
abovementioned nursing efforts, which are responsible for the observed health gains (Fonseca et al.,
2012).
1.4 Advanced Therapies for Arterial leg ulcers
There is n't enough data to back up the usage of sophisticated treatments on a regular basis.
Advanced therapy, on the other hand, should be examined to speed up healing of wounds in
individuals who are at high risk of amputee. 60 As a result, enhanced treatments should only be
explored in rare cases when the normal best practice strategy to wound repair is failing to
provide satisfying results. Prior to deciding to employ a certain advanced therapy, access to it,
the availability of educated health professionals, the cost, and the appropriateness of treatment
should all be considered. It's crucial to realize that although sophisticated treatments may help
arterial ulcers heal, they don't treat the underlying condition. Unless contraindicated, enough
blood circulation must be reestablished whenever feasible to maintain recovery. Advanced
treatments, when paired with revascularization, have the potential to enhance wound healing
results (Federman et al., 2016; Beaumier et al., 2021).

PUBLIC
Alternative therapy approaches are continuously being discovered by several researchers (Shape,
2013).
1.4.1 MiRNA modulation
The development of miRNAs has resulted in a plethora of new therapeutic possibilities.
Understanding the role of miRNA in wound healing regulation and creating better miRNA

PUBLIC
modulation methods in the skin would aid in converting this information towards highly
effective treatments (Banerjee et al., 2011; Schneider et al., 2012).
1.4.2 Genetic therapies
The findings of a HFE genetic diagnosis may have a significant impact on therapeutic
management. The existence of the C282Y mutation could increase the criteria for surgical
treatment of superficial venous stasis and position this higher on the list of priorities (Singh et al.,
2010).
1.4.3 Therapies targeting Integrin receptors
Modifications in receptor molecules define chronic wounds (integrins). Activating or inhibiting
integrin receptors with different substances might be a powerful way to influence healing of
wounds (Widgerow, 2013).
1.4.4 Allogeneic neonatal keratinocytes
Despite the requirement for tissue engineering, peripheral arterial disease ulcers may be treated
employing an aerosol mixture of allogeneic newborn keratinocytes and fibroblasts every 14 days
at an optimal concentration of cells per mL (Kirsner et al., 2012).
1.4.5. Regenerative therapeutics
The curative efficacy of stem cells is being used in regenerative medicine to stimulate skin
rejuvenation. The capacity to comprehend and manage such progenitor cellular components to
enhance skin regeneration is the potential of regenerative medicine, and biomaterials would
remain to serve a key influence for tissue regeneration through supplying the foundation for
reconstructing functioning domains. Stem cell-based treatments have a lot of promise in skin
healing after damage or illness. Most strata of skin surface include functional stem cell units, and
the stem cell niche is the collection of physiochemical micro - environmental stimuli that allow
this regeneration potential. The interfollicular epidermis, follicle bulge, perivascular spaces and
dermal papillae, have been studied as specialty regeneration model structures. These findings
imply that stem cell techniques for skin remodeling should take into account the niches' complex
molecular and biologic characteristics. Progenitor-cell-mediated skin healing and regeneration

PUBLIC
will be aided by innovative biomaterial solutions that effectively mimic these microclimates
(Wong et al., 2012).
1.4.6 Immunological therapeutic
As per Frade et al., (2011) using organic biomembrane containing latex isolated by Hevea
brasiliensis proved suitable as a dressing since it did not cause hypersensitivity responses in
patch experiment participants or recipients of the natural biomembrane, respectively empirically
and immunologically confirmed by IgE concentrations.
The vegetal biomembrane has been crucial for ability to heal signal transduction, particularly
during the inflammation phase, as evidenced by the copious debridement and exudation of
lesions in regards towards the control management of pain venous ulcers, that also appears to be
related directly to strenuous vasculature forming accompanied by reepithelialization (Frade et al.,
2012).
1.4.7 Topical F5 agent
In rodents, a 115-aa fraction of released Hsp90 (F-5) serves as an unusual wound repair factor,
according to the authors. F-5 peptide was considerably highly efficacious than PDGF-BB at
promoting wound closure in mice with acute and diabetic wounds (Cheng et al., 2011).

PUBLIC
Chapter Three
Methodology
3.1 Introduction
The section would highlight the various methods used to evaluate existing literature on the use of
dressings and topical medicines in the treatment of arterial leg ulcers. Consequently, leg ulcers
are becoming a worldwide concern with a rising incidence of cases, making it challenging to use
modern treatments and provide adequate care management. Diverse studies rigorously analyzed
the method regarding inclusion and exclusion criterion for treatments available for arterial leg
ulcers, as well as patient outcomes. This section would additionally discuss the methodological
grounds for specific publications chosen. In this systematic review, methodology refers to a
hypothetical assessment of methodologies utilized in a research topic. It entails a theoretical
examination of the processes and ideologies associated with cognitive segregation. According to
Boland et al (2013), methodology is the act of locating pertinent publications and then analyzing
them to determine whether publications fulfill both the inclusion and exclusion criteria
(Sileyew,2019). This comprises perspectives such as standards, a theoretical paradigm, and
phases that involve qualitative and quantitative methodologies (Thawfik et al., 2019, Smith et al.,
2011 and Singh et al., 2012).
3.2 Ethical considerations
In most cases, systematic reviewers will rarely possess immediate accessibility to subjects in the
main research papers they are reviewing. With regard to the review purpose, systematic
reviewers should ethically examine overall relevance and quality underlying evidence given in
primary research findings (Suri, 2019).

PUBLIC
3.3 Research Design
A systematic review is characterized as a research that uses a systematic manner to synthesize
data on a set of issues and includes a thorough and complete research strategy. This entails a
comprehensive and repeatable synthesis of the findings of all accessible publications on a certain
subject or clinical concern. The process is explained in an organized way that execute a
systematic review to enhance scientific research (Behghadami and Janati, 2020; Munn et al.,
2018).
With connection towards the research issue, a systematic review could consolidate and assess
pertinent literatures supporting evidentiary foundation. These questions seek to improve the
study's as well as prospective investigators' expertise and abilities. The optimal gold benchmark
in integrating and studying topics and addressing associated challenges has been established as
systematic review (Munn et al., 2018). As a result, systematic reviews strive to provide
researchers access proof of evidence for both published and unpublished resources. It also
guarantees that the results are transparent (Thawfik et al., 2019; Hemingway and Brereton,
2009). It's doesn't rely on a solitary discovery, rather primarily instantiates the entire corpus with
in study's ideal objectives (Smith et al., 2011; Tuchman and Harper, 2012).
As a consequence, a systematic review was used to reduce bias and enhance precision while
using evidence-based practice to provide a valid and trustworthy conclusion (Melnyk and
Fineout-Overholt, 2011). The necessity of detecting discrepancy in a research aids in increasing
precision, allowing decision makers to overcome the issue of disparities in research designs
selection (Behghadami and Janati, 2020). The acronym (PICO) (P represents for Population, I for
Intervention, C for Comparison, and O for Outcome) framework was utilized to help in this
procedure (Behghadami and Janati, 2020; Cochrane, 2014).
3.4 Search criteria
The main search engines that were used to retrieve literature articles and postulate the research
questions were Science direct, Cochrane library, Google scholar and PUBMED. Free-text

PUBLIC
phrases as well as associated suitable topic indexing (MeSH) anticipated to return eligible
research are included in search techniques. The keywords utilized are illustrated in Appendix.
Manual search included scanning reference listings of selected papers; next, conducting citation
tracking, that involves examining electronic databases for all publications that cite each of the
included articles; and finally, analogous to citation tracking (Tawfik, 2019).
The PICO paradigm is frequently employed to construct a systematic review's search strategy.
According to preexisting recommendations, the searching strategic approach must include
population, intervention(s), and research design characteristics (Frandsen et al., 2020;
Behghadami and Janati, 2020). Hence this research employed the Search strategy as:
Population: all females and males with no age limitation with arterial leg ulcer
Innervation: topical agents and dressings on aterial leg ulcer treatment,
Comparison: There is no dressing/topical agent, and additional dressings or local agents are not
allowed. Comparators for placebos
Outcome: patient experience or healing.
3.5 Criterion of Inclusion/Exclusion
The systematic review's inclusion and exclusion criteria were designed revolving on the PICO
paradigm. As proposed by Frandsen et al. (2020), this guaranteed that the study topic was
pursued and that adequately constructed research publications were located. Unrelated,
duplicates, inaccessible complete contents, or abstract-only articles are the most common
exclusion factors. To avoid bias in the research, such exclusions must be specified in beforehand.
Publications containing the target patients, researched treatments, or a comparative of two
studied therapies would be the inclusion criteria. In a nutshell, publications that offer information
that answers our study query (Tawfik, 2019).
The inclusion criteria of this research included articles within the year ranges of 2000-2021,
which included the key words revolving around the research question on the comparison of
dressing and topical agents in the wound healing of arterial leg ulcer. In order to ensure that the

PUBLIC
review is conducted with recent researches and to be manageable to be handled literature from
the above year ranges were selected. On the contrary Randomized trails, RCT, clinical trials,
ongoing studies, Double blind studies were included in the inclusion criterion.
In the process of exclusion key factors emphasized by Taylor et al., (2014) was followed which
involves: exclusion of literature that's not in English, Human participants not in study, reviews
published are over 10 years old, abstracts, inability to extract data. In this systematic review the
exclusion criteria included absence of healing data, the outcomes of therapeutic intervention not
included, insufficient data to draw aetiology of ulcer, comparator not available and the outcome
are not within scope, duplicates were removed. However, one clinical trial by Roman (1991) was
included as it was the only research that included the comparison of topical agents with a
placebo.
Here total 136 papers found in the first literary searches from different databases. The quantity
was reduced to 79 after a second search utilizing the key terms and filtering out unrelated
articles. Nonetheless, additional publications were scrutinized for assessment, glancing just at
abstract and content, as well as the number of articles was reduced to 35 as a result of the
systematic review procedure (Greenhalgh, 2014). As a result, the method of qualifying
requirements was used to minimize bias and enhance accuracy on content appropriateness and
suitability, resulting in the research resources being reduced to five publications.

PUBLIC
3.6 Selection of articles
Source: Moher et al.,2009

PUBLIC
3. 7 Quality framework and appraisal
The systematic approach of determining quality that has been utilized to discover relevant papers
throughout the investigation study and to assess the validity and efficacy of the results is known
as critical appraisal (Tod, Booth and Smith, 2021). The Critical Evaluation Skills Programme
(CASP) instrument, which has been endorsed by the Cochrane Qualitative and Implementation
Methods Group, is the most often employed instrument promoting competence appraising in
health-related qualitative evidence syntheses (Long, French and Brooks, 2020). A minimum of
two researchers is recommended in the crucial assessment procedure (Tod, Booth and Smith,
2021; Cochrane, 2009). It is to confirm the research's legitimacy; yet, this research was
conducted independently and under tight monitoring (Bettany-Saltikov, 2010).
3.8 Data extraction and management
The researcher gathered the necessary information in each of the studies that included:
 the trial's location (country, as well as whether it's in primary or secondary care);
 the duration of the follow-up;
 randomization of the number of respondents (or legs or ulceration);
 criterion for inclusion;
 criterion for exclusion;
 treatment and co-intervention descriptions;
 benchmark attributes of categories for key parameters (e.g., age, gender, etc.)
 size and length of ulcer
 the outcome of the trial;
 the examination of intent-to-treat (ITT);
 the frequency of withdrawals and the reasons behind them;
 the financing sources;
 the usage of a population size computation that is done ahead of time.

PUBLIC
Chapter Four
4. Results
Rooman and Janssen conducted an eight-week experiment in which they compared a 2 percent
ketanserin ointment in PEG to a control cohort which administered PEG twice daily (Rooman
1991). There were 19 individuals in the ketanserin group versus 21 participants with in controls
(PEG alone) cohort among those with solely arterial illness. 299 people with decubitus ulcers
were included in this multicenter study: 80 had pressure ulcers, 134 had venous ulcers, 45 had
diabetic ulcers, and 40 had arterial ulcers.
The mechanism for distinguishing the participants was not described in the report. The features
of individuals selected through a tertiary reference center or perhaps a routine healthcare
environment could likely be distinct, e.g., length with ulcers, degree of underlying disease, and
this might have an influence on the transferability of the findings to other settings. The trial's
inclusion and exclusion parameters, as well as the extent underlying arterial damage in each
cohort, were not reported. The trial's sole endpoint for the arterial limb ulceration segment were
lesion surface as a proportion of duration, and therefore couldn't tell how long it took to reach
50% recovery given experimental graphic of findings.
Rooman 1991 presented the study as a double-blind, placebo-controlled trial, but did not
elaborate on the measures employed to guarantee that doctors and individuals were uninformed
of the therapy (ketanserin or control). Rooman (1991) chose not to disclose on the effectiveness
of the blindness, nor on if the personnel evaluating the wound by obtaining wound
reconstructions were also blindfolded. Subjects, employees, and result assessors were not
blinded, according to Santoro 2018. As a result, both studies' efficiency and detecting biases
were assessed overall 'unclear.'
61 people suffering non-healing ulcers took participation in Santoro 2018. (30 in the standard
dressing group and 31 in CGF group). Arterial diabetic ulcers, Venous ulcers, neuropathic ulcers,
vasculitic ulcers traumatized ulcers were among the causes. This study assessed topical
administration of concentrated growth factors (CGF) to a typical polyurethane film or foam
dressing, each administered weekly for six weeks. The number of patients suffering arterial
diabetic ulcers with in CGF cohort was recorded in the study, whereas the incidence of arterial

PUBLIC
diabetic ulcers there in usual dressing cohort was not published.CGF had been an allogeneic
formulation made from the participants' own blood, which was thought to be high in platelet-
derived growth elements including vascular endothelial growth factor, transforming growth
factor beta1-2, fibroblast growth factor, stem cells and insulin-like growth factor. For estimating
the ulcer size, the researchers employed MOWA graphical software (Mobile Wound Analyzer).
A sole result recorded by ulcer aetiology in the Rooman 1991 research was ulcer size as a time -
dependent, which was shown as a graphic. Rooman 1991 hypothesized that participants
receiving ketanserin would reach 50% healing in 3.5 weeks and those in the comparison group
will indeed surpass 50% recovery in 6.3 weeks, implying that ketanserin-treated respondents
fully recovered nearly 3 times as swiftly as control-treated individuals ("1.8 fold"; Rooman
1991), which was statistically significant at P 0.01. Although the ulcer region remained a
proportion of the beginning size, the average ulcer size in the control group was higher at the
start of the trial than in the ketanserin group, which might bias the findings (ketanserin 9.41 cm2;
control 11.03 cm2).
The main endpoint in Santoro 2018 was a lesion diminution of at minimum 50% in area and
proportion of lesions after six weeks of therapy.Researchers found that 19/31 (61.3%) of the
CGF group accomplished this, relative to 2/30 (6.7%) of the normal dressings reference cohort.
Nine individuals in the CGF subgroup experienced arterial diabetic ulceration, with six of them
(66.6 percent) experienced at least a 50% decrease in ulceration diameter. This research did not
provide subgroups information regarding diabetic arterial ulceration with in conventional
dressing cohort, hence a relevant connection with the competent control cluster was not feasible.
According to the investigations of Vuerstaek et al., 2006, the average timeframe towards
completed recovery in the V.A.C. category was 29 days (95 percent confidence interval [CI],
25.5 to 32.5) vs 45 days (95 percent CI, 36.2 to 53.8) in the control group (P =.0001).
Furthermore, wounds bedding preparations took 7 days (95 percent CI 5.7 to 8.3) after V.A.C.
treatment vs 17 days (95 percent CI 10 to 24, P =.005) during traditional wound management.
Traditional wound management expenditures were greater than either V.A.C. At the conclusion
of treatment, both groups demonstrated a substantial improvement overall quality of life and a
considerable reduction in pain levels.

PUBLIC
Amato et Al., 2019 highlighted among individuals suffering heterogeneous ulceration, a multi-
center randomised control study was conducted. The enrolled patients received wound dressing
therapy according to the methods for groups A and B of patients, together using elastic
compression, for a period of 12 weeks. Throughout the initial 12 weeks of surveillance, all
participants in group A (53/53) had full healing of wounds: 11 individuals. (20.7%) following
five weeks, 14 patients (26.4%) after 6 weeks, ten patients (18.8%) after seven weeks, eight
individuals (15.0%) following eight weeks, seven patients (13.2%) during nine weeks, two
patients (3.7%) after ten weeks, and one patient (1.8%) after eleven weeks. Just 32 of the 47
patients (68 percent) in group B had ulcers heal in the first phase of the study (12 weeks from
first observation), with succeeding scheduling: in 2 patients (4.2 percent) in the first 5 weeks; in
1 patient (2.1 percent) in 6 weeks; in 3 patients (6.3 percent) in 8 weeks; in 5 patients (10.5
percent) in 9 weeks; in 7 patients (14.8 percent) in 10 weeks; in 6 patients (13.9 percent) in 11
weeks; in 8 patients (18.6 percent) in 12.
Wu et al. (2015) included information from 13 systematic evaluations of 17 RCTs that looked at
the efficacy of bandages for treating diabetic foot ulceration.Hydrogel dressings, and also foam
dressings (2 RCTs, n=49: directly and indirectly documents, odds ratio [OR] 4.32, 95 percent
confidence interval [CI] 1.56 to 9.85: very low quality evidence), have been observed to be
significantly to be statistical significant vastly more efficient than rudimentary wound interaction
dressings for comprehensive healing process (3 RCTs, n=198: direct data, relative risk [RR]
1.80, 95 percent confidence interval [CI] 1.27 to 2.56: low quality evidence). Foam dressings
outperformed alginate dressings in two RCTs (n=50: direct and indirect data, OR 3.61, 95
percent CI 1.30 to 8.30: extremely poor quality proof).

PUBLIC
Chapter 5
Discussion
Rooman (1991) investigated the effects of a 2% ketanserin treatment in polyethylene glycol
(PEG) to a PEG-only reference condition. The experiment comprised a maximum of 299
individuals, with only 40 of them having ulceration owing to vascular insufficiency. Because it
provided a subgroups assessment of the 40 arterial ulceration individuals independently, the
examination was capable of gauging overall research 's results. The lesion region as a relation of
time was the sole result given by ulcer aetiology, and it showed that ketanserin ointment
hastened overall recovery of arterial ulceration (almost times as efficient as the PEG only
placebo group).
Santoro 2018 contrasted the administration of an allogeneic formulation with concentrated
growth factors (CGF) made from the patients' own blood to a conventional dressing
(polyurethane film or foam) administered weekly throughout six weeks. The trialists supplied
critical information regarding diabetic arterial ulceration individually, however solely for the
treatment cohort, making it impossible to contrast to the proper control community. Rooman
(1991) did not record any adverse reactions, while Santoro (2018) stated that no individuals had
any.
While the outcomes of included investigations would seem to be positive, researchers cannot
assertively reach the conclusion that there is amplified healing due to either ketanserin 2 percent
topical application while compared to PEG alone, or due to CGF though when compared to
standard dressing due to the insufficient provision of feedback, in unique combination with
The paucity of reportage of methodologies utilised in the trial (e.g. method of allocation).
Furthermore, the follow-up periods (six and eight weeks) were insufficient to document
sufficient therapeutic episodes to enable us to draw distinctions. The technique of detecting
arterial ulcers was unclear in the included studies due to a scarcity of explicitly specified
inclusion and exclusion criteria, limiting the generalizability of the findings. It's also worth
noting that ketanserin isn't approved for human usage in all nations. We found the information to
be quite poor in terms of certainty for ulcer treatment and very low in terms of consequences and

PUBLIC
recurrence. Neither study documented upon a certain time it took for an ulceration to recover,
patient contentment, or life quality.
The objective for the research was to evaluate dressings and topical treatments in the treatment
of arterial leg ulcers. The searching procedure involves looking for pertinent material within
repositories. These techniques accomplished through combining keywords and Boolean
operators. Although it was indicated in the investigation 's objectives that unpublished material
could be included, it was not done owing to time restrictions, consequently confirmation
selection bias might be present.All analyzed investigations had inadequate procedural quality,
provided minimal technical background, and provided relatively insufficient endpoint
information for the arterial ulceration segment. There have been a small number of volunteers, as
well as the follow-up duration was insufficient. Furthermore, statistics relevant towards the
diabetes arterial ulceration conventional dressing (reference) subgroup could not be extracted. As
a result, the information supplied was insufficient and could not be applied to the larger group of
persons who suffer with arterial ulcerations.
Vuerstaek et al. (2006) shown that V.A.C. treatment contributes to a considerable improvement
in wound care of resistant CLUs in a prospective randomized controlled study. As a result,
V.A.C. treatment must be regarded the preferred therapeutic for CLUs. Additional prospective
investigations with a larger patient population will be required to assess the impact of V.A.C. on
ulceration relapse frequencies.
The complexity of attempting to control variables affiliated to comorbidities; determining
specimen magnitudes to attain statistically significant; attempting to recruit sufficient
respondents; concerns with confirmatory inflammation, infection, and wound dimensions; and
barriers of verifying subjectivity, including such convenience as well as user-friendliness, are all
examples of such dilemmas (Broderick , Pagnamenta and Forster, 2020). Dressings are
classified as'medical devices' in the United Kingdom; they are CE labelled (Conformité
Européenne or European Conformity), indicating that they are safe to employ in the
circumstances for which they were developed, but they are not subjected to the same extensive
testing as pharmaceutical medicines (i.e. drugs).

PUBLIC
As a result, there exists no motivation to sponsor extensive studies. Companies aren't really
compelled by legislation to give proof of efficacy, which contributes to the paucity of study
(Madden 2012). As a result, just proposing more controlled clinical trials (CCTs) or RCTs could
be ineffective. Conversely, it can be proposed that other techniques be investigated in order to
give doctors with some advice on the best strategy to treat arterial leg ulceration. The researchers
constructed steps to avoid author bias by incorporating impartial, repeated inclusion and
exclusion for studies reviewed, potential of bias evaluations, and data retrieval with in evaluation
process (Broderick , Pagnamenta and Forster, 2020). The notion that multiple publications failed
to identify whether their included individuals suffered arterial disease, or didn not provide
specific criteria for a diagnosis which might enable readers to establish arterial disease, raises
concerns about bias in this analysis. Such could perhaps potentially resulted in the exclusion of
research that fulfilled the inclusion criterion (Broderick , Pagnamenta and Forster, 2020).
According to Wu et al., (2015) Cochrane study, there is presently no compelling indications
suggesting any sophisticated dressing form is more successful over conventional wound contact
dressings in treating diabetic foot ulceration. The researchers acknowledged that the predictions
for all of the comparisons are imprecise due to the limited number of RCTs available and the
small number of participants in these trials. In addition, the evidence in the three comparisons
where conclusive proof of such a variation was provided was assessed to be of poor or extremely
poor quality. As a result, the results are described as ambiguous and unsuitable for guiding
management.
A systematic evaluation conducted in 2006 focused at how various dressings affected venous leg
ulcers while worn under compressive dressings (Palfreyman 2006). Despite the fact that Forster
and Pagnamenta (2015) conducted a systematic review that comprised 42 research, the authors
were unable to determine that one style of dressing was better to another. The study was been
divided into several parts to examine the effects using alginate dressing (O'Meara 2013),
hydrocolloid dressings (Ribeiro 2014), foam dressings (O'Meara 2013b), and hydrogel dressings
(Ribeiro 2014). The foam and alginate dressings evaluations revealed minimal improvement in
ulcer healing based upon dressing kind, whereas the hydrocolloid and hydrogel assessments were
being prepared, with just a methodology presently available. Although these studies do not reach

PUBLIC
any implications on arterial ulceration, these do give significant facts about ulcer treatments and
the prevailing depth of understanding and exploration (Forster and Pagnamenta, 2015).
The comparative influence of steps to assist healing of wounds by employing local therapies
including such topical formulations and dressings upon that recovery of arterial ulcerations
remains unknown. Individuals might want to choose between surgical and non-surgical therapy
for their ulcer in certain cases, however there is currently lack of research to tell if the topical
agent/wound dressings composition used has any effect on wound repair(Nelson and Bradley,
2007).Because healing process could be impossible in certain clinical scenarios owing to a lack
of arterial blood flow, the major outcomes in these instances should be the occurrence of
significant consequences (e.g., infection, amputation) and health-related quality of life (Nelson
and Bradley, 2007).

PUBLIC
Chapter Six
Limitations
The objective for the research was to evaluate dressings and topical treatments in the treatment
of arterial leg ulcers. The searching procedure involves looking for pertinent material within
repositories. These techniques accomplished through combining keywords and Boolean
operators. Although it was indicated in the investigation 's objectives that unpublished material
could be included, it was not done owing to time restrictions, consequently confirmation
selection bias might be present.
Because of the wide range of patient demographics, any research investigating which treatment
option to utilize must adopt the design of the study which considers the variances across
individuals. A most effective research method is a randomized control trial (RCT), yet creating a
double-blind RCT in dressings effectiveness is difficult owing to a variety of difficulties.
There are a number of explanations why there is so little high-quality literature on this subject.
Because venous ulceration remains significantly quite common than arterial ulceration,
recruiting adequate people for a study focused solely on arterial lesions is considerably quite
challenging. Subjects in wound management experiments would always differ in a variety of
ways, such as the size and length of the ulceration, overall severity of vascular damage, or
concomitant therapies including such wound cleaning, exercising, diet, as well as other self-care
behaviors.
While conducting analysis throughout the research, it emerged evident there was substantially
insufficient evidence accessible for topical medicines and dressings in the treatment of arterial
leg ulcers than there was for venous leg ulcers. It thus placed me in a predicament, because I had
to ascertain to either revise the investigation topic or proceed with the initial. Assuming I wanted
to do it all over again, I would neither modify the study because of the clear association between
both the usage of tropical agents and dressings in wound healing frequency. Notwithstanding, I'd
want to see the outcomes of a more in-depth systematic evaluation of different treatment
strategies for treating arterial leg ulcers.

PUBLIC
Chapter 7
Conclusion and Recommendations
There is a paucity of information that corroborate or refute the use of dressings or topical
treatments throughout the recovery of arterial ulcerations, according to this study. Previously
noted in chapter on comprehensive validity and application of evidence, there are a number of
obstacles that prevent RCTs for the evaluation on dressing and topical treatments for ulcers from
being designed and conducted. Prospective RCTs or CCTs should counterbalance the variability
deriving with comorbidity, as well as the problems of recruiting as well as validating the
endpoint assessments, to establish that they are relevant to a wide range of persons with arterial
ulcerations and thus valuable to healthcare professionals.
In the recovery of arterial ulcerations, however, these researchers focus are required: •
assessment of different current dressings; • contrast of wound dressings solely with topical
medications placed beneath wound dressings. Such trials ought to have well defined inclusion
and exclusion parameters, as well as a sufficiently extended follow-up period to establish the
efficacy of the treatment.
Various dressing might be particularly suited for different wound states or phases of recovery,
meaning that full recovery may not be the best therapeutic goal for all therapies. More study is
required on the advantages that various kinds of dressings may provide, as well as how to
quantify other outcomes that are important to decision makers (especially clinical staff) such as
exudate control, disease clearance, and side effects. It may be inferred that while selecting
dressings, practitioners should evaluate the unit cost of the dressings, their management qualities,
and the patient's desire.
All the studies that were evaluated emphasizes a key factor of further research due to the lack of
current investigation in the medical arena on therapeutic management of arterial ulcers compared
with the vast quantity of literature articles prevailing for Venous leg ulcer management. It could
be stated that depending on the aetiological form of ulcer, predisposed conditions, patient
demographics the therapeutic interventions would vary.

PUBLIC