The lived experience of recurrence prevention in patients with venous leg ulcers: An interpretative phenomenological study

Aim of the studyTo explore patient understanding of why they develop a venous leg ulcer and how they can prevent recurrence.MethodThe methodological framework of the hermeneutic phenomenological approach was used. Semi-structured interviews were conducted with seventeen participants living with a venous leg ulcer from May 2017 to November 2018. Data were analysed using Smith's interpretative hermeneutic analysis.ResultsThe results are categorised into three main themes: “Trauma due to accident” (initial venous leg ulcer) and “Prevention of ulcer recurrence” (compression); “Trauma due to compression therapy” (venous leg ulcer recurrence). The findings demonstrate active venous leg ulcers are often caused by acute incidents while carrying out an activity in people with underlying chronic venous insufficiency. After a complete healing, preventive measures, such a compression stockings are initiated by the patient or health care provider. Trauma due to adherence to compression stockings caused skin breakdown beneath compression that caused subsequent ulcer recurrence.ConclusionThis study contributes to understanding the lived experience of patients with venous leg ulcers who develop a venous leg ulcer and their understanding of how they can prevent recurrence. Patients with VLUs would benefit from early preventive strategies, such as such a compression stockings fitting and application, integrated into daily care plan of primary care and community settings.     

Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial

Venous leg ulcers (open sores) can be caused by a blockage or breakdown in the veins of the leg. Compression, using bandages or hosiery (stockings), can help heal ulcers, however, they do not always work. Venous ulcer patients are often encouraged to exercise, but little is known about the effects and safety of exercise training in this population. This study therefore tried out supervised exercise training in people in the U.K. who are being treated with compression for a venous leg ulcer. Participants were randomly allocated to receive usual care, or usual care plus a 12‐week supervised exercise programme. The exercise programme involved three sessions per week, with each session involving a combination of walking, cycling and strength and flexibility exercises for the leg muscles. Participants were followed for up to 1 year, with data collected on ulcer healing, quality of life and healthcare use (e.g. visits to GP). Thirty‐nine people were recruited, with 18 being allocated to the exercise group. All but two participants completed the study. The overall exercise session attendance rate was 79%, with 13 participants (72%) completing all sessions. There were no serious adverse events (unwanted side effects). The average ulcer healing time was shorter for the exercise group: 13 versus 35 weeks. These findings support the feasibility of supervised exercise training in people being treated with compression for a venous leg ulcer. A larger study is needed to confirm the effects on ulcer healing and if exercise is cost‐effective.     

Risk factors for the recurrence of venous leg ulcers in adults: A systematic review protocol

BackgroundVenous leg ulcers are slow to heal, and recurrence is frequent. Living with venous leg ulcers can affect physical and psychological health, and result in financial burden for individuals. Physiological and psychosocial factors are associated with venous leg ulcer recurrence. As over 50% of venous leg ulcers will recur within 12 months of healing, a comprehensive knowledge of holistic risk factors associated with recurrence is required by health professionals involved in the care of the person with venous leg ulcers.AimTo develop a systematic review protocol to determine the risk factors for recurrence of venous leg ulcers in adults.Method and AnalysisThis protocol was developed according to the Preferred Reporting Items Form Systematic Review and Meta-Analysis Protocols (PRISMA-P). The inclusion criteria will be based on the PICOS mnemonic-adults with a history of venous leg ulcer/s (participants), risk factor/s under physiological (general/medical), clinical, demographics, psychosocial categories (I (intervention) or E (exposure), venous leg ulcer non-recurrence (comparison group), venous leg ulcer recurrence (outcomes to be measured) and will include study designs of original qualitative, quantitative and mixed method studies (study designs to be included). Methodological quality will be assessed using the Mixed Methods Appraisal Tool. This Systematic Review Protocol was registered in PROSPERO [CRD42021279792].ResultsIf meta-analysis is not possible, a narrative review of results will be presented.ConclusionsThis systematic review on recurrence of venous leg ulcers can provide evidence-based information for preventive strategies for recurrence of a healed venous leg ulcer. The standardised approach outlined in this systematic review protocol offers a rigorous and transparent method to conduct the review.     

What is the effect of larval therapy on the debridement of venous leg ulcers? A systematic review

AimTo determine the impact of larval therapy on the debridement of venous leg ulcers, in comparison to other debridement methods or no debridement.MethodUsing systematic review methodology, published quantitative studies focusing on the effect of larval therapy on the debridement of venous leg ulcers were included. The search was conducted in January 2020 and updated in May 2021 using CINAHL, PubMed, Embase, and the Cochrane library, and returned 357 records, of which six studies met the inclusion criteria. Data were extracted using a predesigned extraction tool and all studies were quality appraised using the RevMan risk of bias assessment tool.ResultsLarval therapy was found to debride at a faster rate than hydrogel (p = 0.011, p < 0.001, p = 0.0039), have a similar effect to sharp debridement (p = 0.12, p = 0.62), and was a resource-effective method of debridement (p < 0.05, p < 0.001, p < 0.001). When larval therapy in combination with compression therapy was compared to compression alone, larvae had a greater effect on debridement (p < 0.05), however, it did not improve overall wound healing rates (p = 0.54, p = 0.664, p = 0.02). Pain levels increased during larval therapy and reduced after treatment, when compared to other standard debridement techniques.ConclusionLarval therapy promotes rapid debridement of venous leg ulcers. However, further high quality randomised controlled trials, comparing larval therapy to other debridement methods for venous leg ulcers, incorporating the use of compression is required to determine the long term effects of larval therapy.     

Intermittent pneumatic compression as an adjuvant therapy in venous ulcer disease

Despite improvements in healing rates venous ulcer disease still carries significant morbidity and cost. Any therapy that further improves healing rates is worthy of consideration. The recognised effects of intermittent pneumatic compression (IPC) on both arterial and venous circulation suggest that its use may confer significant benefits to venous ulcer healing. This study investigates the potential additive effects of adjuvant IPC on the healing and subsequent prevention of venous ulcers. Some improvement in the rate of healing in venous ulcers is noted. These findings are set against a background of very high healing rates in both treatment and control groups. No benefit is seen to accrue if IPC is used as an adjuvant therapy to help prevent recurrence of ulcers although the study period is very short.     

Vascular assessment in venous leg ulcer diagnostics and management in Australian primary care: Clinician experiences

AimIn this article, we focus on primary health clinicians’ experiences of vascular assessment in venous leg ulcer (VLU) diagnostics and management, including ankle brachial pressure index (ABPI) measurements using Doppler ultrasonography.MethodsWe conducted semi-structured face-to-face and telephone interviews with general practitioners [15] and practice nurses [20] from primary health care settings in Australia. Twenty-one participants were recruited from practices located in Melbourne metropolitan settings and 14 from rural Victoria. We used the theory driven thematic analysis as a method of data analysis. The Theoretical Domains Framework informed this analysis.ResultsFive domains were identified as relevant, including Environmental Context and Resources, Motivation and Goals, Skills, Knowledge, and Beliefs about Capabilities. Although the Australian and New Zealand clinical practice guideline for prevention and management of venous leg ulcers recommend that vascular assessment is conducted for all patients with suspected VLUs, findings from our study indicate vascular assessments are not routinely performed in many primary care settings. Our study also found that a lack of awareness of clinical practice guidelines among clinicians might be one of the main issues for not following the latest clinical recommendations for vascular assessment in venous leg ulcer diagnostics and wound management practice.ConclusionWe recommend development of theory-informed interventions for clinicians in primary health care settings to optimise VLU management and healing outcomes for patients with VLUs. Implementation and evaluation of these interventions have the potential to reduce the evidence-practice gap in VLU management and optimise healing outcomes.     

The prevalence,management and outcome for patients with lower limb ulceration identified in a wound care survey within one English health care district

482 people with leg ulcers were identified among those receiving health care in Bradford, UK. Of these wounds 195 (40.4%) were venous leg ulcers. Typically the people who experienced these wounds were elderly Caucasian females however a sub-group of younger males of Asian descent were seen to experience ulcers involving neuropathy. The leg ulcers were typically small in size although 33 people had wounds over 25 cm² in surface area. The leg ulcers tended to persist with many present for at least 1 year with 4 wounds active for over 5 years. 205 people had experienced previous episodes of leg ulcer occurrence. Of the leg ulcers encountered 18.0% (n = 87) were infected and where wounds were swabbed for their microbial burden MRSA was identified in 8.5% of cases. Use of Doppler ultrasound to assess the aetiology of the wound had been performed in 66.4% of cases and where wounds remained undiagnosed (n = 69) only 8 had been Doppler assessed. While 75% of all venous leg ulcers received compression 48 people with venous leg ulcers did not have compression applied to their wound.     

Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers

Background In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients. Aim This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55‐years of age, of short‐stretch compression (SSB), four‐layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression). Method Study period was 24‐weeks, the primary outcome was the patient functional status, disease‐specific and generic health‐related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF‐12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi‐square and the repeated measures analysis of variance test. Results A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047). Conclusion Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment.     

Uso de plasma rico en plaquetas para cicatrización de úlceras crónicas de miembros inferiores

Introduction and objectivesPlatelet-rich plasma (PRP) is used as an adjuvant in the treatment of chronic ulcers of the lower extremity and has shown particularly promising results in the case of neuropathic ulcers. There has been less research, however, into its use in venous and hypertensive ulcers. Our aim was to assess the safety and feasibility of using PRP in the treatment of chronic ulcers of the lower extremity and to evaluate its potential benefits in directed healing.Material and methodsWe prospectively selected 11 patients with nonischemic ulcers of the lower extremity that had been present for at least 6 weeks. PRP was injected subcutaneously into the perilesional tissue and applied topically in 4 sessions held at 1-week intervals. We assessed quality of life (SF-12 questionnaire), pain (visual analog scale), and the circumference of the ulcer before and after treatment.ResultsThere was a predominance of women (8/11, 73%), and venous ulcers (7/11, 64%) were more common than hypertensive ulcers (4/11, 36%). The median age of the patients was 79 years and the median time since onset of the ulcer was 17 months (range, 6-108 months). We observed a significant reduction in pain (P < .05) and a significant improvement in the physical and mental components of the SF-12 (P < .05). The mean reduction in ulcer size was 60%, and complete healing was achieved in 5 cases. No adverse effects were observed.ConclusionThe local application of PRP is a valuable and practical procedure that promotes the healing of chronic ulcers of the lower extremity; it can improve patient quality of life and is particularly effective in local pain relief.     

Changes in quality of life for patients with chronic venous insufficiency,present or healed leg ulcers

Background: Patients with chronic leg ulcers are handicapped in daily life, both by physical complaints and social problems. The aim of our study was not only to assess a possible impairment of quality of life (QOL) of leg ulcer patients but also to evaluate if there is a real improvement of QOL after healing of the ulcer. Patients with chronic venous insufficiency served as the control group. We further analyzed if there were significant differences in the response between patients who were and were not performing compression therapy. Patients and method: We interviewed three groups of patients (active venous leg ulcer, healed venous leg ulcer and patients with chronic venous insufficiency using the ?Freiburger Life Quality Assessment für Venenerkrankungen“ (FLQAv). Results: Physical problems, daily handicaps and social problems all increased with age. Contrary to our expectations, healing of a leg ulcer did not lead to a significant increase in QOL. Instead, patients with active ulcers did not regard their QOL as lower than those in the other groups. Compression therapy also did not impair QOL in the three groups. Conclusion: Even though ulcer healing is an admirable goal, it does not necessarily lead to an improved QOL, probably because of the numerous comorbidi‐ties in this patient group. Nonetheless, it is important to control problems associated directly with the wound to allow ulcer patients to participate actively in everyday life and minimize social problems.     

Surrounding skin management in venous leg ulcers: A systematic review

ObjectivesChronic venous insufficiency may lead to the development of venous leg ulcers, the most common form of chronic wounds in the lower extremity. Key to venous leg ulcer care is the maintenance of healthy skin surrounding the ulcer, as failure to maintain skin integrity may influence the healing outcome. We thus reviewed the scientific literature looking for assessment and management instruments regarding this common but often neglected issue.MethodThe search included all studies published between 2000 and May 2019. Keywords used were: “peri-wound skin care”, “surrounding skin venous ulcers”, “surrounding skin management leg ulcers”, and “peri-lesional skin management”.ResultsManagement of moisture-balance with the selection of appropriate dressings is the most important target in surrounding-wound skin care. Moreover, contact dermatitis related to products and the dressings themselves is a neglected problem in patients with chronic leg ulcers which clinicians increasingly have to manage. The literature search revealed that there is an increasing interest in the use of noninvasive assessment tools in the field of wound care, and focusing on the surrounding-wound skin plays a role in assessing the potential of wound healing. Transepidermal water loss measurement (TEWL) and ultrasonography are two of the measurement techniques available.ConclusionThe integrity of the surrounding skin is necessary for wound healing, and appropriate management is needed to address this aspect which is part of an overall approach to treating wounds.     

Topical zinc oxide treatment improves arterial and venous leg ulcers

We performed a randomized, double-blind study of the efficacy of locally applied zinc oxide on the healing of leg ulcers. Thirty-seven geriatric patients, nineteen with arterial and eighteen with venous leg ulcers, were treated either with a gauze compress medicated with zinc oxide (400 μg ZnO/cm²) or with an identical compress without zinc oxide. The treatment was assessed from ulcer size measurements and the presence or abscncc of granulation and ulcer debridement over a period of 8 weeks. The zinc-treated patients (83% success rate) responded significantly better (P <0·05) than the placebo-treated patients (42% success rate). The results suggest that healing of leg ulcers is improved after the addition of zinc oxide to the local regimen.     

Removal of dermal edema with class I and II compression stockings in patients with lipodermatosclerosis

Background: Lipodermatosclerosis is a sequela of deep venous insufficiency and a risk factor for the occurrence of venous leg ulceration. Medical compression stockings facilitate leg ulcer healing and prevent occurrence of ulcers resulting from removal of edema. Although the exact level of compression necessary for removal of dermal edema in patients with deep venous insufficiency has not been established, garments providing high compressive values of 30 to 40 mm Hg have been recommended. Dermal edema can be visualized by high-frequency ultrasonography. Objective: We used ultrasound imaging to study whether a lower level of compression (class I 18 to 26 mm Hg vs class II 26 to 36 mm Hg) is effective in removal of dermal edema. This question is important because the use of hosiery with a lower compression class would enhance compliance and enable treatment of patients with mixed arteriovenous disease. Methods: In 11 patients skin images were obtained with 20 MHz ultrasound from the malleolar region in lipodermatosclerotic skin and corresponding normal skin of the contralateral leg. The ratio of low echogenic pixel number to total pixel number (LEP/TP), which correlates with dermal water, was measured before and after 5 days of applied compression in two treatment courses where classes of compression were switched randomly. Ankle circumference was also measured. Results: We found that LEP/TP was 33% higher in lipodermatosclerotic skin than in the matched normal skin indicating presence of skin edema. Application of class I and II compressive hosiery resulted in LEP/TP decrease by 17% (95% confidence interval, 0.07 to 0.26) and 14% (95% confidence interval, 0.04 to 0.21), respectively, suggestive of dermal edema reduction. No statistically significant difference in efficacy of dermal edema removal between class I and II was found. No changes in ankle circumference after application of both classes of compression was observed. Conclusion: Application of light and moderate compression results in a partial edema removal from the dermis in lipodermatosclerosis in the absence of measurable reduction in leg circumference. Class I compression is as effective as class II for elimination of dermal edema. These data indicate that light compression may be a useful modality for patients with deep venous insufficiency and lipodermatosclerosis who are not eligible for treatment with garments having higher compressive forces. (J Am Acad Dermatol 1998;39:966-70.)     

The role of low resistance blood flow pathways in the pathogenesis and healing of venous leg ulcers

In an attempt to clarify the pathophysiology of haemodynamics in legs with venous ulcer we investigated the effect of a single intermittent pneumatic compression treatment on the peripheral resistance of leg arteries and the cutaneous laser Doppler flux in the leg. Eight patients with venous leg ulcers and 10 subjects with healthy legs were investigated. Doppler waveforms of the leg arteries and laser Doppler flux of the leg skin were recorded before and after a single intermittent pneumatic compression treatment with the subjects in a recumbent position. In the legs with venous ulcer, the peripheral resistance of the arteries was lower and the laser Doppler flux was greater, compared with healthy legs (p = 0.003 and p = 0.002, respectively). A single intermittent pneumatic compression treatment raised the peripheral resistance in the arteries of legs with ulcer and laser Doppler flux of the skin more in ulcer legs than in healthy legs (p = 0.046 and p = 0.034, respectively). These findings suggest that removal of oedema causes redistribution of skin blood flow in the legs with venous ulcer favouring the superficial capillary perfusion. This could explain why compression treatment promotes the healing of venous leg ulcers.     

Local treatment of chronic cutaneous leg ulcers with recombinant human granulocyte-macrophage colony-stimulating factor

AIM: To test the efficacy and safety of recombinant granulocyte-macrophage colony-stimulating factor (rHuGM-CSF) in the treatment of chronic cutaneous leg ulcers. METHODS: Five patients with chronic cutaneous leg ulcers were recruited for this 4-month study using only rHuGM-CSF to treat the ulcers. One patient had a neuropathic-diabetic ulcer, and four had long-standing vascular leg ulcers. RESULTS: The patient with the neuropathic diabetic ulcer showed complete healing after 1 month of treatment. The other four patients with vascular leg ulcers with a long history of ulceration had a poor prognosis for healing. The first, with three venous ulcerative lesions, presented complete resolution of one ulcer and stabilization of the other two; the second and third patients, with large vascular ulcers, improved with more then 50% reduction of the mean diameter of the ulcers; the fourth patient, with one large venous ulcer, did not show any improvement. CONCLUSIONS: Pathogenesis, size and duration of the ulcers seemed to be the most important parameters regarding wound repairing capability of rHuGM-CSF. None of the ulcers increased in size and none of the patients developed clinical side-effects or peripheral blood cell count abnormalities during the treatment. All the results described were stable after 6 months of follow up. The absence of peripheral leucocyte count variation and the size-dependent therapeutic effect indicate that the drug exercises local rather than systemic actions.     

Prognostic indicators in venous ulcers

BACKGROUND: Venous ulcers can be difficult to heal, and prognostic factors for healing have not been fully elucidated. OBJECTIVE: The objective of this study was to analyze the results of a large multicenter venous ulcer trial to retrospectively establish prognostic factors for venous ulcer healing. METHODS: This study examined data from a previously published prospective randomized placebo-controlled trial of an oral medication versus placebo treatment for venous ulcers. Local leg ulcer care involved the use of a moisture-retentive dressing and sustained graduated compression with a paste bandage and a self-adherent wrap. The oral medication or placebo was administered on a daily basis with the same dressings and bandage system in both groups for 12 weeks. A total of 165 patients completed the full 12-week treatment period; 83 received ifetroban, 82 received placebo. RESULTS: There was no statistically significant difference in outcome between the two groups. The study showed that consistent local ulcer treatment with a clearly defined system of care was associated with an unexpectedly high percentage (55%) of long-standing large venous ulcers (mean duration, 27 months; mean area, 15.9 cm(2)) being healed in both groups. Baseline ulcer area and duration of leg ulcer were found to be important in predicting outcome. Ulcers of short duration were found to be most likely to heal. Percent healing and ulcer area at week 3 were good predictors of 100% healing. Ulcers that had at least 40% healing by week 3 predicted more than 70% of the outcomes correctly. CONCLUSION: From this large study it was determined that baseline ulcer area and ulcer duration are significant predictors of 100% healing and time to heal. Percent healing and ulcer area at week 3 are good predictors of complete ulcer healing. Ulcers that are large, long-standing, and slow to heal after 3 weeks of optimal therapy are unlikely to heal rapidly, and might benefit from alternative therapies.     

Evaluation of timolol maleate gel for management of hard-to-heal chronic venous leg ulcers. Phase II randomised-controlled study

BackgroundVenous leg ulcers (VLUs) often take a very long time to heal. Timolol maleate has been reported as displaying efficacy in healing of VLUs.ObjectivesTo evaluate the efficacy of timolol maleate gel in the management of hard-to-heal VLUs and to assess its safety as a topical agent during 12 weeks of use in combination with conventional treatment.MethodsA prospective, phase-II randomised-controlled trial with a sample size based on Fleming's one-stage design (P0 = 0.25, P1 = 0.45, alpha = 0.1, beta = 0.2) was planned. Patients with VLUs present for ≥ 24 weeks and with ≥ 50% granulation tissue were included. One drop of sustained-release timolol gel (Timoptol® LP 0.5%, Santen, Tampere, Finland) per 6 cm² VLU area was applied every 2 days for 12 weeks in timolol-treated patients, as adjuvant therapy to the standard care protocol (interface dressing and multilayer venous compression). Controls received standard care alone. The primary endpoint was to obtain ≥ 40% reduction in ulcer area at week 12 (W12).ResultsForty-three patients were randomised to the study, with 40 receiving at least one treatment and included in the analysis: 21 timolol-treated patients and 19 controls (females: 70%; median age: 72.5 [range 35–93] years). At W12, ≥ 40% ulcer-area reduction was achieved in 14/21 (67%) timolol-treated patients vs. 6/19 (32%) controls. No serious adverse events occurred. Local wound infections not requiring systemic antibiotics occurred in 5 cases in the timolol group and in one case in the controls.ConclusionsThese results support the benefit and safety of using timolol maleate to manage hard-to-heal VLUs, but confirmation is required in a larger multicentre randomised phase-III study.