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Background

Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: ‘four-layer bandage’ (4LB) and ‘short-stretch bandage’ (SSB).

Methods

We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009–2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant’s first year.

Results

Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [−32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [−0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%.

Conclusions

Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.

Trial registration

ClinicalTrials.gov Identifier: NCT00202267

This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB.

Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses.

Design: Randomised controlled trial with 1 year of follow up.

Setting: Eight community based research clinics in four trusts in Trent.

Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group.

Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group).

Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored.

Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89).

Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Key messages Leg ulcer clinics based in the community using four layer compression bandaging can be more clinically effective than usual care provided by the district nursing service Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care It is difficult to measure improvements in health related quality of life among people with venous leg ulcers

OBJECTIVE--To evaluate the effectiveness of community clinics for leg ulcers. DESIGN--All patients with leg ulceration were invited to community clinics that offered treatment developed in a hospital research clinic. Patients without serious arterial disease (Doppler ankle/brachial index > 0.8) were treated with a high compression bandage of four layers. SETTING--Six community clinics held in health centres in Riverside District Health Authority supported by the Charing Cross vascular surgical service. PATIENTS--All patients referred to the community services with leg ulceration, irrespective of cause and duration of ulceration. MAIN OUTCOME MEASURES--Time to complete healing by the life table method. RESULTS--550 ulcerated legs were seen in 475 patients of mean (SD) age 73.8 (11.9) years. There were 477 venous ulcers of median size 4.2 cm2 (range 0.1-117 cm2), 128 being larger than 10 cm2. These ulcers had been present for a median of three months (range one week to 63 years) with 150 present for over one year. Four layer bandaging in the community clinics achieved complete healing in 318 (69%) venous ulcers by 12 weeks and 375 (83%) by 24 weeks. There were 56 patients with an ankle/brachial arterial pressure index < 0.8, indicating arterial disease. The 50 patients with pressure index < 0.8 > 0.5 were treated with reduced compression, and 24 (56%) healed by 12 weeks and 31 (75%) by 24 weeks. The figures for overall healing for all leg ulcers were 351/550 (67%) at 12 weeks and 417/550 (81%) at 24 weeks, compared with only 11/51 (22%) at 12 weeks before the community clinics were set up. CONCLUSIONS--Community clinics for venous ulcers offer an effective means of achieving healing in most patients with leg ulcers.

OBJECTIVE--To determine the effect of oxpentifylline on the healing of venous ulcers of the leg. DESIGN--Double blind, randomised, prospective, placebo controlled, parallel group study. SETTING--Four outpatient clinics treating leg ulcers in England and the Republic of Ireland. PATIENTS--80 Consecutive patients with clinical evidence of venous ulceration of the leg in whom appreciable arterial disease was excluded by the ratio of ankle to brachial systolic pressure being greater than 0.8. INTERVENTIONS--All patients received either oxpentifylline 400 mg three times a day by mouth or a matching placebo for six months (or until their reference ulcer healed if this occurred sooner) in addition to a locally standardised method of compression bandaging. MAIN OUTCOME MEASURES--The primary end point was complete healing of the reference ulcer within six months. The secondary end point was the change in the area of the ulcer over the six month observation period. RESULTS--Complete healing of the reference ulcer occurred in 23 of the 38 patients treated with oxpentifylline and in 12 of the 42 patients treated with a placebo. Life table analysis showed that the proportion of ulcers healed at six months was 64% in the group treated with oxpentifylline compared with 34% in the group treated with a placebo (log rank test chi 2 = 4.78, p = 0.03), which was significant (odds ratio = 1.81, 95% confidence interval 1.20 to 2.71). CONCLUSION--Oxpentifylline used in conjunction with compression bandaging improves the healing of venous ulcers of the leg.

Objective To compare the effectiveness of two types of compression treatment (four layer bandage and short stretch bandage) in people with venous leg ulceration.

Design Systematic review and meta-analysis of patient level data.

Data sources Electronic databases (the Cochrane Central Register of Controlled Trials, the Cochrane Wounds Group Specialised Register, Medline, Embase, CINAHL, and National Research Register) and reference lists of retrieved articles searched to identify relevant trials and primary investigators. Primary investigators of eligible trials were invited to contribute raw data for re-analysis.

Review methods Randomised controlled trials of four layer bandage compared with short stretch bandage in people with venous leg ulceration were eligible for inclusion. The primary outcome for the meta-analysis was time to healing. Cox proportional hazards models were run to compare the methods in terms of time to healing with adjustment for independent predictors of healing. Secondary outcomes included incidence and number of adverse events per patient.

Results Seven eligible trials were identified (887 patients), and patient level data were retrieved for five (797 patients, 90% of known randomised patients). The four layer bandage was associated with significantly shorter time to healing: hazard ratio (95% confidence interval) from multifactorial model based on five trials was 1.31 (1.09 to 1.58), P=0.005. Larger ulcer area at baseline, more chronic ulceration, and previous ulceration were all independent predictors of delayed healing. Data from two trials showed no evidence of a difference in adverse event profiles between the two bandage types.

Conclusions Venous leg ulcers in patients treated with four layer bandages heal faster, on average, than those of people treated with the short stretch bandage. Benefits were consistent across patients with differing prognostic profiles.

STUDY OBJECTIVE--Comparison of four layer bandage system with traditional adhesive plaster bandaging in terms of (a) compression achieved and (b) healing of venous ulcers. DESIGN--Part of larger randomised trial of five different dressings. SETTING--Outpatient venous ulcer clinic in university hospital. PATIENTS--(a) Pressure exerted by both bandage systems was measured in the same 20 patients. (b) Healing with the four layer bandage was assessed in 148 legs in 126 consecutive patients (mean age 71 (SE 2); range 30-96) with chronic venous ulcers that had resisted treatment with traditional bandaging for a mean of 27.2 (SE 8) months. INTERVENTIONS--(a) Four layer bandage system or traditional adhesive plaster bandaging for pressure studies; (b) four layer bandaging applied weekly for studies of healing. END POINTS--(a) Comparison of pressures achieved at the ankle for up to one week; (b) complete healing within 12 weeks. MEASUREMENTS AND MAIN RESULTS--(a) Four layer bandage produced higher initial pressures at the ankle of 42.5 (SE 1) mm Hg compared with 29.8 (1.8) for the adhesive plaster (p less than 0.001; 95% confidence interval 18.5 to 6.9). Pressure was maintained for one week with the four layer bandage but fell to 10.4 (3.5) mm Hg at 24 hours with adhesive plaster bandaging. (b) After weekly bandaging with the four layer bandage 110 of 48 venous ulcers had healed completely within 12 (mean 6.3 (0.4)) weeks. CONCLUSION--Sustained compression of over 40 mm Hg achieved with a multilayer bandage results in rapid healing of chronic venous ulcers that have failed to heal in many months of compression at lower pressures with more conventional bandages.

Objective To assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers.

Design Multicentre, pragmatic, two arm randomised controlled trial.

Setting Community and district nurse led services, community leg ulcer clinics, and hospital outpatient leg ulcer clinics in 12 urban and rural settings (11 in the United Kingdom and one in the Republic of Ireland).

Participants 337 patients with at least one venous leg ulcer of >6 months’ duration or >5 cm2 area and an ankle brachial pressure index of ≥0.8.

Interventions Weekly administration of low dose, high frequency ultrasound therapy (0.5 W/cm2, 1 MHz, pulsed pattern of 1:4) for up to 12 weeks plus standard care compared with standard care alone.

Main outcome measures Primary outcome was time to healing of the largest eligible leg ulcer. Secondary outcomes were proportion of patients healed by 12 months, percentage and absolute change in ulcer size, proportion of time participants were ulcer-free, health related quality of life, and adverse events.

Results The two groups showed no significant difference in the time to healing of the reference leg ulcer (log rank test, P=0.61). After adjustment for baseline ulcer area, baseline ulcer duration, use of compression bandaging, and study centre, there was still no evidence of a difference in time to healing (hazard ratio 0.99 (95% confidence interval 0.70 to 1.40), P=0.97). The median time to healing of the reference leg ulcer was inestimable. There was no significant difference between groups in the proportion of participants with all ulcers healed by 12 months (72/168 in ultrasound group v 78/169 in standard care group, P=0.39 for Fisher’s exact test) nor in the change in ulcer size at four weeks by treatment group (model estimate 0.05 (95% CI –0.09 to 0.19)). There was no difference in time to complete healing of all ulcers (log rank test, P=0.61), with median time to healing of 328 days (95% CI 235 to inestimable) with standard care and 365 days (224 days to inestimable) with ultrasound. There was no evidence of a difference in rates of recurrence of healed ulcers (17/31 with ultrasound v 14/31 with standard care, P=0.68 for Fisher’s exact test). There was no difference between the two groups in health related quality of life, both for the physical component score (model estimate 0.69 (–1.79 to 3.08)) and the mental component score (model estimate –0.93 (–3.30 to 1.44)), but there were significantly more adverse events in the ultrasound group (model estimate 0.30 (0.01 to 0.60)). There was a significant relation between time to ulcer healing and baseline ulcer area (hazard ratio 0.64 (0.55 to 0.75)) and baseline ulcer duration (hazard ratio 0.59 (0.50 to 0.71)), with larger and older ulcers taking longer to heal. In addition, those centres with high recruitment rates had the highest healing rates.

Conclusions Low dose, high frequency ultrasound administered weekly for 12 weeks during dressing changes in addition to standard care did not increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence.

Trial registration ISRCTN21175670 and National Research Register N0484162339

Background

Chronic wounds are managed almost entirely by community nurses. Almost all individuals with leg ulcers report acute pain usually related to dressing change. Little is known about pain after healing. The purpose of this study was to explore the course of pain from baseline to time of healing of leg ulcers (venous or mixed etiology). In order to understand this phenomenon and develop implications for nursing practice, objectives included: 1) Measure incidence and prevalence of pain at baseline and healing; 2) Describe characteristics associated with leg ulcer pain at baseline; 3) Identify predictors of leg ulcer pain at healing.

Methods

Data were from one randomized controlled trial (2004-2008) of 424 individuals with leg ulcers in the community receiving evidence-informed nursing management. The primary outcome was pain at the time of healing. Predictive factors included demographic, circumstance of living, clinical and ulcer characteristics. Multivariable logistic regression identified the subset of predictors of pain at healing. Odds ratios (OR) and 95% confidence intervals (CI) are reported.

Results

Eighty-two percent of participants reported pain at baseline and 32% at healing. Five percent with no pain at baseline reported pain at healing. Thirty-seven percent reported moderate to severe pain at baseline and 11% at healing. Twenty percent of all those who healed reported pain interfered with work moderately to extremely at time of healing. Being female (OR=1.64, 95% CI 1.00, 2.68, p=0.05), use of short-stretch vs. four-layer bandages (OR=1.73, 95% CI 1.06, 2.82, p=0.03), lower SF-12 PCS (OR=0.97, 95% CI 0.94, 0.99, p=0.02) and MCS (OR=0.98, 95% CI 0.95-1.00, p=0.04) scores, use of non-steroidal anti-inflammatory drugs (OR=2.28, 95% CI 1.06, 4.88, p=0.03), and tender pain (OR=2.17, 95% CI 1.29, 3.66, p=<0.01) were associated with pain at time of healing.

Conclusions

Pain is an issue on admission for chronic wounds and at healing, yet 58% with moderate to severe pain on admission were not taking pain medication(s). Future studies should examine the role of pain at healing and at subsequent ulcer recurrence. Mobility and other factors that may contribute to pain at time of healing should also be assessed. Community nurses are encouraged to consider pain when planning care on admission and also after wound healing, when most patients are discharged from care.

Trial registration

ClinicalTrials.gov, NCT00202267

OBJECTIVE--To determine which social and clinical factors are associated with healing in patients with venous ulceration. DESIGN--Patients were questioned about social factors at their first visit to a community ulcer clinic. They were treated by high compression bandage system and were interviewed again after 12 weeks. SETTING--Community leg ulcer clinics held in health centres throughout Riverside Health Authority in London. PATIENTS--All patients referred to five community leg ulcer clinics with venous ulceration over a six month period. MAIN OUTCOME MEASURES--These were factors significantly associated with healing within 12 weeks of beginning treatment, measured by odds ratio (OR) given by logistic regression analysis. MAIN RESULTS--Of 168 patients with venous ulceration, 87 (52%) healed after 12 weeks of treatment. Univariate analysis showed that low social class (OR = 3.44, 95% CI 1.17, 10.14), lack of central heating (OR = 2.22, 95% CI 1.18, 4.18), and being single (OR = 2.77, 95% CI 1.15, 6.69) were all significantly associated with delayed healing. After adjustment for the known risk factors of ulcer size, ulcer duration, and general mobility only lack of central heating was still significant (OR = 2.27, 95% CI 1.11, 4.55). The remaining factors failing to achieve statistical significance because of their inter-relationship with the known risk factors. CONCLUSIONS--Clinical features of the ulcer seem to determine the progress of healing in patients with leg ulceration. Although there were associations between socio-economic factors and poor healing, adjustment for clinical risk factors generally led to lower non-significant associations. Only lack of central heating retained its association and may play a part in prolonging healing of venous ulceration.

Background

The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.

Methods/Design

The trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm2 or >10 cm2. Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.

Discussion

The aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.

Trial Registration

ACTRN12608000599370

Venous ulcers are the most common ulcers of the lower limb. It has a high morbidity and results in economic strain both at a personal and at a state level. Chronic venous hypertension either due to primary or secondary venous disease with perforator paucity, destruction or incompetence resulting in reflux is the underlying pathology, but inflammatory reactions mediated through leucocytes, platelet adhesion, formation of pericapillary fibrin cuff, growth factors and macromolecules trapped in tissue result in tissue hypoxia, cell death and ulceration. Duplex scan with colour flow is the most useful investigation for venous disease supplying information about patency, reflux, effects of proximal and distal compression, Valsalva maneuver and effects of muscle contraction. Most venous disease can be managed conservatively by leg elevation and compression bandaging. Drugs of proven benefit in venous disease are pentoxifylline and aspirin, but they work best in conjunction with compression therapy. Once ulceration is chronic or the patient does not respond to or cannot maintain conservative regime, surgical intervention treating the underlying venous hypertension and cover for the ulcer is necessary. The different modalities like sclerotherapy, ligation and stripping of superficial varicose veins, endoscopic subfascial perforator ligation, endovenous laser or radiofrequency ablation have similar long-term results, although short-term recovery is best with radiofrequency and foam sclerotherapy. For deep venous reflux, surgical modalities include repair of incompetent venous valves or transplant or transposition of a competent vein segment with normal valves to replace a post-thrombotic destroyed portion of the deep vein.

Objective To compare the clinical effectiveness of larval therapy with a standard debridement technique (hydrogel) for sloughy or necrotic leg ulcers.

Design Pragmatic, three armed randomised controlled trial.

Setting Community nurse led services, hospital wards, and hospital outpatient leg ulcer clinics in urban and rural settings, United Kingdom.

Participants 267 patients with at least one venous or mixed venous and arterial ulcer with at least 25% coverage of slough or necrotic tissue, and an ankle brachial pressure index of 0.6 or more.

Interventions Loose larvae, bagged larvae, and hydrogel.

Main outcome measures The primary outcome was time to healing of the largest eligible ulcer. Secondary outcomes were time to debridement, health related quality of life (SF-12), bacterial load, presence of meticillin resistant Staphylococcus aureus, adverse events, and ulcer related pain (visual analogue scale, from 0 mm for no pain to 150 mm for worst pain imaginable).

Results Time to healing was not significantly different between the loose or bagged larvae group and the hydrogel group (hazard ratio for healing using larvae v hydrogel 1.13, 95% confidence interval 0.76 to 1.68; P=0.54). Larval therapy significantly reduced the time to debridement (2.31, 1.65 to 3.2; P<0.001). Health related quality of life and change in bacterial load over time were not significantly different between the groups. 6.7% of participants had MRSA at baseline. No difference was found between larval therapy and hydrogel in their ability to eradicate MRSA by the end of the debridement phase (75% (9/12) v 50% (3/6); P=0.34), although this comparison was underpowered. Mean ulcer related pain scores were higher in either larvae group compared with hydrogel (mean difference in pain score: loose larvae v hydrogel 46.74 (95% confidence interval 32.44 to 61.04), P<0.001; bagged larvae v hydrogel 38.58 (23.46 to 53.70), P<0.001).

Conclusions Larval therapy did not improve the rate of healing of sloughy or necrotic leg ulcers or reduce bacterial load compared with hydrogel but did significantly reduce the time to debridement and increase ulcer pain.

Trial registration Current Controlled Trials ISRCTN55114812 and National Research Register N0484123692.

Objective

To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.

Design

Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.

Setting

Leg ulcer clinics of a teaching and a district general hospital in southern Scotland.

Participants

200 patients with confirmed venous ulcers and in whom other major causal factors were excluded.

Interventions

Pentoxifylline 400 mg three times daily or placebo.

Main outcome measure

Complete healing (full epithelialisation) of all ulcers on the trial leg.

Results

Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.

Conclusions

The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.

Key messagesLeg ulcers cost the NHS around £400 million per annum50%-75% of venous leg ulcers can be succesfully treated with dressings and compression bandages but take many months to healA drug that reduced the healing time of venous ulcers would be useful, although no agent has been proved to be effective to dateTrials with pentoxifylline, a vasoactive drug used in the treatment of peripheral vascular diseases, as an adjunct to the treatment of venous ulcers have been inconclusiveAt the 5% level, pentoxifylline had a non-significant effect on healing rates of pure venous ulcers

Peripheral vascular disease affects some 12%–14% of the general population, and the majority of people with the disease are asymptomatic. The Ankle Brachial Pressure Index (ABPI) test is widely used by a diverse range of practitioners (in the community and hospital setting) in order to screen asymptomatic patients, diagnose patients with clinical symptoms, and to monitor patients who have had radiological or surgical intervention. This paper explains the theoretical basis of the ABPI test, as well as the relevance of the common modifications of the test. It explores the background to the quoted normal ranges for the ABPI test. It reviews the large body of literature that has developed on the association between ABPI and cardiovascular risk, as well as ABPI as a predictor for cardiovascular morbidity and mortality, highlighting the evidence that can inform practice. The review looks critically at the limitations of the ABPI test, providing practitioners with an evidence-based update on the importance and challenges of standardizing ABPI methodology. This paper highlights the influence of the key technical aspects of the ABPI test that all practitioners need to consider in order to be able to make more reliable and informed management decisions based on ABPI findings.

A consecutive series of 50 patients with large leg ulcers (surface area > 100 cm2) were investigated for evidence of arterial, venous and nutritional problems. Arterial insufficiency was found in 34%, venous reflux in 50%. A group of eight patients had no arterial or venous problem but had serious deficiencies of vitamin C and zinc. Arterial bypass was performed successfully in 15 of the 17 patients with arterial disease. All patients had a mesh split-skin graft. The 25 with venous incompetence had compression bandaging; in these patients the ulcer had healed on discharge but 10 had recurrent ulceration within 6 months. The leg ulcers in patients with corrected arterial insufficiency healed significantly more rapidly than those with venous incompetence. The ulcers in those with nutritional deficiency healed promptly after skin grafting and correction of the deficiency. It is important to be aware of arterial insufficiency and nutritional deficiency in patients with leg ulcers, as such deficiencies may contribute to the non-healing of an apparently straightforward leg ulcer.

Background

Venous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3% of the adult population at some time in life, and which corresponds to approximately 75% of all chronic ulcers of the leg. Multilayer compression bandaging is, at present, the only treatment that has been proved to be effective in treating this type of ulcer. There is no consensus, however, about the dressings that may be applied, beneath the compression, to promote the healing of this type of ulcer, as there does not seem to be any added benefit from using special dressings rather than simple, low-adherence ones. As well as analgesia, acupuncture provokes peripheral vasodilation, in skin and muscles – which has been demonstrated both experimentally and in clinical practice – probably due to the axon reflex, among other mechanisms. The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings, in comparison with low-adherence ones and acupuncture.

Methods/design

Cluster-randomized open-labeled trial, at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District, with a control group treated with compression bandaging and low-adherence dressings; the experiment will consist, on the one hand, of the compression treatment applied in combination with special dressings (Treatment 1), and on the other, the compression treatment applied in association with low-adherence dressings, together with acupuncture (Treatment 2).

Discussion

The results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer, and the rate of complete healing at 3 months after beginning the treatment. An economic analysis will also be made.

This study, carried out in the context of real clinical practice, will provide information for decision-taking concerning the effectiveness of special dressings. Moreover, for the first time a high-quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers.

Trial registration

Current Controlled Trials ISRCTN26438275.

Objective To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression.

Design Randomised controlled trial.

Setting Specialist nurse led leg ulcer clinics in three UK vascular centres.

Participants 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux.

Interventions Compression alone or compression plus saphenous surgery.

Main outcome measures Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time.

Results Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test).

Conclusion Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time.

Trial registration Current Controlled Trials ISRCTN07549334.

Aim

This randomized clinical trial was conducted 2008 – 2009 to investigate a cryotherapy (cooling) gel wrap applied to lower leg skin affected by chronic venous disorders to determine whether therapeutic cooling improves skin microcirculation. Impaired skin microcirculation contributes to venous leg ulcer development, thus new prevention therapies should address the microcirculation to prevent venous leg ulcers.

Data Sources

Sixty participants (n = 30 per group) were randomized to receive one of two daily 30-minute interventions for four weeks. The treatment group applied the cryotherapy gel wrap around the affected lower leg skin, or compression and elevated the legs on a special pillow each evening at bedtime. The standard care group wore compression and elevated the legs only.

Laboratory pre- and post-measures included microcirculation measures of skin temperature with a thermistor, blood flow with a laser Doppler flowmeter, and venous refill time with a photoplethysmograph.

Review methods

Data were analysed using descriptive statistics, paired t-tests or Wilcoxon signed ranks tests, logistic regression analyses, and mixed model analyses.

Results

Fifty-seven participants (treatment = 28; standard care = 29) completed the study. The mean age was 62 years, 70% female, 50% African American. In the final adjusted model, there was a statistically significant decrease in blood flow between the two groups (−6.2[−11.8; −0.6], P = 0.03). No statistically significant differences were noted in temperature or venous refill time.

Conclusion

Study findings suggest that cryotherapy improves blood flow by slowing movement within the microcirculation and thus might potentially provide a therapeutic benefit to prevent leg ulcers.

Introduction

The aim of the research was to compare the dynamics of venous ulcer healing when treated with the use of compression stockings as well as original two- and four-layer bandage systems.

Material and methods

A group of 46 patients suffering from venous ulcers was studied. This group consisted of 36 (78.3%) women and 10 (21.70%) men aged between 41 and 88 years (the average age was 66.6 years and the median was 67). Patients were randomized into three groups, for treatment with the ProGuide two-layer system, Profore four-layer compression, and with the use of compression stockings class II. In the case of multi-layer compression, compression ensuring 40 mmHg blood pressure at ankle level was used.

Results

In all patients, independently of the type of compression therapy, a few significant statistical changes of ulceration area in time were observed (Student’s t test for matched pairs, p < 0.05). The largest loss of ulceration area in each of the successive measurements was observed in patients treated with the four-layer system – on average 0.63 cm2/per week. The smallest loss of ulceration area was observed in patients using compression stockings – on average 0.44 cm2/per week. However, the observed differences were not statistically significant (Kruskal-Wallis test H = 4.45, p > 0.05).

Conclusions

A systematic compression therapy, applied with preliminary blood pressure of 40 mmHg, is an effective method of conservative treatment of venous ulcers. Compression stockings and prepared systems of multi-layer compression were characterized by similar clinical effectiveness.

OBJECTIVE--To evaluate the prognostic factors in uncomplicated venous leg ulcer healing. DESIGN--Randomised parallel group controlled trial with subjects stratified by initial ulcer diameter and four months' maximum duration of follow up. SETTING--Assessment at Northwick Park Hospital vascular unit with community based treatment. PATIENTS--200 patients with clinical and objective evidence of uncomplicated venous leg ulceration and an initial ulcer diameter > 2 cm. MAIN OUTCOME MEASURE--Time to complete healing of the ulcer. RESULTS--In the presence of graduated compression healing occurred more rapidly in patients with a smaller initial ulcer area (relative risk of healing 1.92 associated with halving of ulcer area (95% confidence interval 1.58 to 2.33)), shorter duration of ulceration (relative risk 1.35 associated with halving duration (1.17 to 1.56)), younger age (relative risk 1.34 associated with 10 year decrease (1.12 to 1.59)), and no deep vein involvement (relative risk 1.8 (1.19 to 2.78)). CONCLUSION--These prognostic factors used in a simple scoring system predict time to healing.

OBJECTIVE: To determine family physicians' perceptions of and attitudes toward leg ulcer care and awareness of effective treatments for venous leg ulcers. DESIGN: Self-administered, cross-sectional faxed and mailed survey. SETTING: Ottawa-Carleton, Ont. PARTICIPANTS: All physicians in the region who were members of the College of Family Physicians of Canada. RESULTS: Response rate was 62%. During 1 month, 107 physicians reported having 226 patients with leg ulcers; only a few patients had had ultrasound assessment. Few physicians (16%) were confident about managing leg ulcers; 61% reported not knowing enough about wound-care products. More than 50% were unaware that compression is effective treatment for venous ulcers. Problems reported were lack of evidence-based clinical practice guidelines for leg ulcer care (82%); absence of evidence-based protocols in home-care agencies (72%); lack of access to wound-care products (69%) and wound-care centres (66%); and poor communication among health care workers (60%). CONCLUSION: Better access to diagnostic assessments and use of compression therapy for venous leg ulcers would improve care.

Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes. Studies with periodontal fibroblasts indicate that attachment to these structures increases the endogenous secretion of multiple growth factors and cell proliferation. Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins. A randomized controlled trial (RCT) involving patients with hard-to-heal venous leg ulcers (VLUs) (ie, ulcers with a surface area ≥10 cm2 and duration of ≥6 months) showed that the application of amelogenin (Xelma®, Molnlycke Health Care, Gothenburg, Sweden) as an adjunct treatment to compression results in significant reduction in ulcer size, improvement in the state of ulcers, reduced pain, and a larger proportion of ulcers with low levels of exudate, compared with treatment with compression alone. Amelogenin therapy was also shown to be safe to use in that there were no significant differences in adverse events noted between patients treated with amelogenin plus compression and those treated with compression alone. Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in “real life” situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers.

OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers. METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted. MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period. STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers. RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems. CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.

Graduated compression stockings are used in both surgical and non-surgical treatment of varicose veins. In a trial of high versus low compression stockings (40 mmHg vs 15 mmHg at ankle) after varicose vein surgery, both were equally effective in controlling bruising and thrombophlebitis, but low compression stockings proved to be more comfortable. In a further trial after sclerotherapy, high compression stockings alone produced comparable results to Elastocrepe bandages with stockings. It is concluded that after varicose vein surgery low compression stockings provide adequate support for the leg and that after sclerotherapy, bandaging is not required if a high compression stocking is used.