Community Leg Ulcer Clinics Research Articles

Comparison of compression therapy use, lower limb wound prevalence and nursing activity in England: a multisite audit

This audit was designed to identify the need of the population and the clinical activity associated with wounds and the management of lower limb swelling. The exploration focused on lower leg wound management, access to diagnostics and compression therapy across each audit site. The variation across the sites was explored to gather insight into the real-world barriers to providing evidence-based management for leg ulceration. We undertook wound prevalence audits across six diverse community provider sites in England. The audit was undertaken by the local providers, with the inclusion of tissue viability and podiatry leads and key local stakeholders, often local quality leads, primary care leads and nursing directors. Each audit was undertaken with full engagement of local clinicians. Data were collected centrally, and each audit site received their own local analysis and report, with additional analytical support from the local tissue viability lead to ensure the feedback was contextualised for their stakeholders. Analysis was provided by Accelerate CIC Lymphoedema & Leg Ulcer Clinic. A total of 2885 patients were reviewed via an online or a paper audit tool. In total, 2721 patients had one or more active wounds. However, 1350 patients had one or more lower leg wounds, with 164 patients being managed for lower limb swelling or prevention of leg ulceration; bilateral conditions ranged from 11-43% across audit sites. Of the six sites, two included both community and primary care providers, thus generating wound point prevalence data. The remaining four sites audited community nursing and podiatry services only, with two sites collecting data on lower limb wounds only rather than all wounds, generating point prevalence for their services only. Compression usage varied across care locations, with the greatest use being seen in community leg ulcer clinics, where it was >96% for 234 residents. Compression usage was lower in the home with a range of 14-62% among 692 residents. For 263 residents, where the cause of their lower leg wound was unknown, compression usage was very low at 12%. Compression usage decreased with age; for three audit sites this was noteworthy, with 65% of those aged >80 years not in receipt of compression. Compression usage had a direct impact on nursing activity; non-use of compression increased activity by 37%. Through the identification of wound location, this series of wound prevalence audits identified a greater number of patients with lower limb wounds than those recognised and classified as a leg ulcer. Substantial variation in access to diagnostics and compression therapy was observed between audit sites, and also between locations within their boroughs. The factors that reduced access to compression therapy included not classifying the lower leg wound as a leg ulcer, being cared for in the home and increasing age of the patient. Lack of compression usage increased nursing activity. Where there is lack of access to therapeutic intervention, the resultant patient harm is not systematically recognised or documented.

VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers

To compare the clinical effectiveness and cost-effectiveness of low-dose ultrasound delivered in conjunction with standard care against standard care alone in the treatment of hard-to-heal venous ulcers. A multicentre, pragmatic, two-armed randomised controlled trial with an economic evaluation. Community nurse services; community leg ulcer clinics; hospital outpatient leg ulcer clinics, among both urban and rural settings in England, Scotland, Northern Ireland and Ireland. Patients with a venous leg ulcer of > 6 months' duration or > 5 cm2 and an ankle-brachial pressure index of ≥ 0.8. In total, 337 patients were recruited to the study. Participants in the intervention group received low-dose ultrasound (0.5 W/cm2) delivered at 1 MHz, pulsed pattern of 1 : 4, applied to periulcer skin (via a water-based contact gel) weekly for up to 12 weeks alongside standard care. Standard care consisted of low-adherent dressings and compression therapy, renewed as recommended by the patient's nurse and modified if required to reflect changes in ulcer and skin condition. The output of the ultrasound machines was checked every 3 months to confirm intervention fidelity. The primary end point was time to healing of the largest eligible ulcer (reference ulcer). Secondary outcomes were time to healing of all ulcers, proportion of patients healed, percentage and absolute change in ulcer size, proportion of time patients were ulcer free, cost of treatments, health-related quality of life (HRQoL), adverse events, withdrawal and loss to follow-up. There was a small, and statistically not significant, difference in the median time to complete ulcer healing of all ulcers in favour of standard care [median 328 days, 95% confidence interval (CI) 235 days, inestimable] compared with ultrasound (median 365 days, 95% CI 224 days, inestimable). There was no difference between groups in the proportion of patients with ulcers healed at 12 months (72/168 in ultrasound vs 78/169 standard care), nor in the change in ulcer size at 4 weeks. There was no evidence of a difference in recurrence of healed ulcers. There was no difference in HRQoL [measured using the Short Form questionnaire-12 items (SF-12)] between the two groups. There were more adverse events with ultrasound than with standard care. Ultrasound therapy as an adjuvant to standard care was found not to be a cost-effective treatment when compared with standard care. The mean cost of ultrasound was £197.88 (bias-corrected 95% CI -£35.19 to £420.32) higher than standard care per participant per year. There was a significant relationship between ulcer healing and area and duration at baseline. In addition, those centres with high recruitment rates had the highest healing rates. Low-dose ultrasound, delivered weekly during dressing changes, added to the package of current best practice (dressings, compression therapy) did not increase ulcer healing rates, affect quality of life (QoL) or reduce recurrence. It was associated with higher costs and more adverse events. There is no evidence that adding low-dose ultrasound to standard care for 'hard-to-heal' ulcers aids healing, improves QoL or reduces recurrence. It increases costs and adverse events. The relationship between ulcer healing rates and patient recruitment is worthy of further study. Current Controlled Trials ISRCTN21175670. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 13. See the HTA programme website for further project information.

Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial

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,...

VenUS II: a randomised controlled trial of larval therapy in the management of leg ulcers

To compare the clinical effectiveness and cost-effectiveness of larval therapy with a standard debridement technique (hydrogel). A pragmatic, three-arm, randomised controlled trial with an economic evaluation. Community nursing services, community leg ulcer clinics and hospital outpatient leg ulcer clinics. A range of urban and rural settings. Patients with venous or mixed venous/arterial ulcers (minimum ankle brachial pressure index of 0.6) where a minimum of 25% of ulcer area was covered by slough and/or necrotic material. Loose larval therapy and bagged larval therapy compared with hydrogel. The primary end point was complete healing of the largest eligible ulcer. The primary outcome was time to complete healing of the reference ulcer. Secondary outcomes were: time to debridement, cost of treatments, health-related quality of life (including ulcer-related pain), bacterial load, presence of methicillin-resistant Staphylococcus aureus and staff and patient attitudes to and beliefs about larval therapy. Between July 2004 and May 2007 the trial recruited 267 people aged 20-94 years at trial entry. There were more female (n = 158) than male (n = 109) participants and most ulcers were classified by the nurse as having an area greater than 5 cm(2). The time to healing for the three treatment arms was compared using the log rank test. The difference in time to healing in the three treatments was not statistically significant at the 5% level. Adjustment was then made for stratification and prespecified prognostic factors (centre, baseline ulcer area, ulcer duration and type of ulcer) using a Cox proportional hazards model. No difference was found in healing rates between the loose and bagged larvae groups. Results for larvae (loose and bagged pooled) compared with hydrogel showed no evidence of a difference in time to healing. When the same analytical steps were used to investigate time to debridement, larvae-treated ulcers debrided significantly more rapidly than hydrogel-treated ulcers; however, the difference in time to debridement between loose and bagged larvae was not significant. The adjusted analysis reported the hazard of debriding at any time for those in loose and bagged larvae groups as approximately twice that of the hydrogel group. No differences in health-related quality of life or bacteriology were observed between trial arms. Larval therapy was associated with significantly more ulcer-related pain than hydrogel. Our base-case economic evaluation showed large decision uncertainty associated with the cost-effectiveness of larval therapy compared with hydrogel, suggesting that larval therapy and hydrogel therapy have similar costs and effects in the treatment of sloughy and/or necrotic leg ulcers. Larval therapy significantly reduced the time to debridement of sloughy and/or necrotic, chronic venous and mixed venous/arterial leg ulcers, compared with hydrogel; however, larval therapy did not significantly increase the rate of healing of the ulcers. It was impossible to distinguish between larval therapy and hydrogel in terms of cost-effectiveness. Future research should investigate the association of debridement and healing and the value of debridement as a clinical outcome for patients and clinicians. To inform decision-makers' selection of debriding agents where debridement is the treatment goal, decision analytic modelling of all alternative debridement treatments is required. Current Controlled Trials ISRCTN55114812.

Are community leg ulcer clinics more cost-effective than home care visits?

The literature suggests that leg ulcer clinics are more expensive than home visits, but are associated with faster healing times. Providing district nurses with better postgraduate education on wound care may make better use of this resource.

Retracted: Manuka honey vs. hydrogel – a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers

Comparison of desloughing efficacy after four weeks and healing outcomes after 12 weeks in sloughy venous leg ulcers treated with Manuka honey (Woundcare 18+) vs. standard hydrogel therapy (IntraSite Gel). Expert opinion suggests that Manuka honey is effective as a desloughing agent but clinical evidence in the form of a randomised controlled trial is not available. There is a paucity of research which uses Manuka honey in venous ulcers. Prospective, multicentre, open label randomised controlled trial. Randomisation was via remote telephone. One hundred and eight patients with venous leg ulcers having >or=50% wound area covered in slough, not taking antibiotics or immunosuppressant therapy were recruited from vascular centres, acute and community care hospitals and leg ulcer clinics. The efficacy of WoundCare 18+ to deslough the wounds after four weeks and its impact on healing after 12 weeks when compared with IntraSite Gel control was determined. Treatment was applied weekly for four weeks and follow-up was made at week 12. At week 4, mean % reduction in slough was 67% WoundCare 18+ vs. 52.9% IntraSite Gel (p = 0.054). Mean wound area covered in slough reduced to 29% and 43%, respectively (p = 0.065). Median reduction in wound size was 34% vs. 13% (p = 0.001). At 12 weeks, 44% vs. 33% healed (p = 0.037). Wounds having >50% reduction in slough had greater probability of healing at week 12 (95% confidence interval 1.12, 9.7; risk ratio 3.3; p = 0.029). Infection developed in 6 of the WoundCare 18+ group vs. 12 in the IntraSite Gel group. The WoundCare 18+ group had increased incidence of healing, effective desloughing and a lower incidence of infection than the control. Manuka honey has therapeutic value and further research is required to examine its use in other wound aetiologies. This study confirms that Manuka honey may be considered by clinicians for use in sloughy venous ulcers. Additionally, effective desloughing significantly improves healing outcomes.

Non-medical prescribing in community leg ulcer clinics

Non-medical prescribing in community leg ulcer clinics

Non-medical prescibing in nurse-led community leg ulcer clinics

Over the past decade, nurse prescribing in the community has improved clinical care, providing timely access to many products required for patients to receive appropriate treatment. Until recently, nurses who have qualified as nurse prescribers have only been able to prescribe from a limited list of products. Within the leg ulcer clinic environment, the majority of prescriptions written have been related to wound care. This article describes the introduction of extended independent prescribing (now known as non-medical prescribing) and how this type of prescribing has scope for revolutionizing clinical practice in all healthcare settings. There are, however, many contentious issues for clinicians prescribing in this new role, including systems for communication, clinical governance, and attitudes of other professionals.

Sociodemographic factors in chronic leg ulceration

While there is a commonly held belief that leg ulceration is associated with social factors, the evidence to support this is mainly anecdotal. To determine deficits in sociodemographic status in patients with chronic leg ulceration. In a matched case-control study carried out in community leg ulcer clinics and participants' homes within Wandsworth Primary Care Trust, patients with chronic leg ulceration were compared with age- and sex-matched community controls drawn from general practitioner registers. Main outcome measures were the prevalence of social class, ethnicity, marital status, living status and social support. Data were analysed by conditional logistic regression. In all, 113 patients were identified and matched to controls. Patients had a mean age of 75 years (range 31-94), with 72 (64%) being women. The ulcer had been present for a median of 8 months (range 0.8-144), and 29% of patients had an area of ulceration >10 cm(2) (range 0.5-171.5). Being Afro-Caribbean increased the risk of leg ulceration eightfold (95% confidence interval, CI 1.83-34.75; P < 0.001) compared with the white population. There was a gradient with social class, with patients with leg ulcers being more likely to come from social class IV and V (odds ratio, OR 2.82, 95% CI 1.19-6.74; P = 0.015). Never having married (OR 2.98, 95% CI 1.15-7.74; P = 0.025), living in rented housing (P < 0.001) and having a mobility deficit (P < 0.001) more often occurred in the ulcer patients, while living with a spouse was protective (OR 0.46, 95% CI 0.21-0.99; P = 0.048). Patients with ulceration experienced significantly poorer social support than their controls for most subscales of the medical outcomes study social support questionnaire (all P < 0.05). Chronic leg ulceration is associated with poorer socioeconomic status, and factors which relate to social isolation. At present it is not possible to determine whether these associations are causative or are a consequence of the ulceration.

Should ABPI be measured in patients with healed venous leg ulcers every three months?

To assess if three-monthly reassessment of ABPI is necessary and to determine the possibility of identifying which patients may benefit from more frequent reassessment. The sample comprised 88 consecutive patients with 175 limbs attending community leg ulcer clinics for reassessment after leg ulcer healing had been achieved with compression therapy. Outcome measures were: a fall in ABPI to below 0.8, months between reassessments and arterial disease history. ABPI fell from above 0.8 to below 0.8 in seven limbs in six patients over time periods of between six and 24 months. Of these seven limbs, six had an ABPI between 0.8 and 1.0 at the initial assessment, indicating they had some arterial impairment. ABPI fell below 0.7 (0.58) in only one patient, and this was detected at a six-month reassessment. None of the patients with no or just one arterial symptom experienced a reduction in ABPI to below 0.8. Those whose ABPIs fell below this level had two or more arterial symptoms. Three-monthly reassessment of healed limbs is not recommended as most patients who initially have an ABPI above 1.0 are unlikely to change during this time. However, patients with two or more arterial risk factors, diabetes and an initial ABPI of below 1.0 are likely to need closer monitoring. More in-depth research is needed to examine this problem.

Patient involvement must be a key aspect of choosing an appropriate regimen for leg ulcer management

The final article in a six-part series on leg ulcers focuses on developing leg ulcer services in the community and stresses the importance of taking a holistic approach and the value of patient/carer education to promote concordance.

Quality of life in a trial of short stretch versus four-layer bandaging in the management of chronic venous ulceration

Objective: To evaluate health-related quality of life (HRQoL) in a prospective randomized trial of patients suffering from venous ulceration comparing a generic four-layer elastic bandage (4LB) with a new cohesive short stretch bandage system (CSSB). Methods: Randomized prospective open parallel groups trial in community leg ulcer clinics within twelve trusts in England and Northern Ireland. Patients newly presenting for treatment suffering from chronic venous ulceration, with ankle brachial pressure index (ABPI) &gt;0.8 were entered into the trial. Patients were asked to complete the Nottingham Health Profile (NHP) at entry, at end of trial period (withdrawal or healing), and at 24 weeks. Principal analysis was the comparison of final NHP scores using linear regression with baseline scores entered as a covariate. Results: In all, 154 of the 156 patients who entered the trial completed the initial questionnaire, with 139/154 (90.2%) patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks. The improvements were significantly greater in the 114 patients whose ulcers had healed compared with the 40 whose ulcers remained open in the domains of bodily pain (mean difference [d]=13.2, 95% CI 3.6-22.9, P =0.008), emotional reactions (d=10.5, 95% CI 2.8-18.1, P =0.007) and social isolation (d=8.5, 95% CI 1.2-15.9, P =0.024). There were similar mean scores between the 72 patients treated with the 4LB and the 82 patients treated with CSSB for all domains of the NHP, the largest adjusted difference favoured CSSB for energy (d=3.6, 95% CI-4.3-11.4, P =0.37). Conclusions: Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.

A Modern Leg Ulcer Service

Aim: To define the components and organization of a modern leg ulcer service that is acceptable to patients cost effective and produces high quality outcomes. Method: Analysis of data from published literature as well as experience from the organisation of a leg ulcer service in Gloucestershire. Synthesis: Assessment of leg ulcers requires the services of a vascular laboratory to assess the venous and arteria systems. Effective systems of compression must be employed. Staff and patients must be educated to understand the principals behind their use. For some patients pinch-grafting may be appropriate. Where arterial disease is present in the lower limb, reconstructive surgery should be used for the lower limb vessels The organisation of such a service must ensure good liaison between General Practitioners, community nurses and hospital specialists. Many patients may be managed in community leg ulcer clinics. In some cases, the advice of specialists such as rheumatologists and dermatologists may be required. Conclusions: A national framework for leg ulceir management is needed within which resources are made available in a way that satisfy local needs. Such a framework must be based on management protocols derived from evidence-based practices that have been developed through the experiences of modern leg ulcer services.

When is reduced-compression bandaging safe and effective?

During a one-year period 44 patients were treated with reduced-compression bandaging in the vascular unit at a district general hospital. Twenty patients with venous ulcers were referred from community leg ulcer clinics because they could not tolerate standard compression bandaging (group 1). A further 24 patients had mixed aetiology leg ulcers (group 2), and high-compression bandaging was not attempted because of significant peripheral vascular disease (ankle brachial pressure index < 0.8). Forty-two patients tolerated reduced-compression bandaging without discomfort or skin pressure changes. Healing was achieved in 32 patients (13 in group 1 and 19 in group 2). All non-healed ulcers were considered smaller at the time of final follow-up, and had less exudate. Reduced-compression bandaging has been shown to be effective and well tolerated by patients with venous ulcers who cannot comply with high-compression bandaging. With close supervision, it is safe to use in patients with significant peripheral vascular disease.

Surgery reduces long-term recurrence rate in chronic venous leg ulcers

Abstract Background Surgical correction of isolated superficial venous reflux in ulcerated legs reduces short-term recurrence rates but little is known about long-term recurrence. This study aimed to assess the influence of venous reflux pattern and appropriate surgical correction on ulcer healing and long-term recurrence. Methods Patients with chronic leg ulcers were assessed prospectively at a one-stop clinic over 4 years to July 1999. Patients with an ankle: brachial pressure index (ABPI) greater than 0·85, including those with diabetes mellitus and rheumatoid arthritis, were treated with weekly four-layer bandaging in community leg ulcer clinics. Venous duplex studies in all ulcerated legs assessed venous reflux pattern and patients with isolated superficial reflux were offered surgery. Patients were advised to wear class 2 elastic compression stockings after healing and were reviewed at 1, 3, 6 and 9 months, and at 1, 2 and 3 years. Ipsilateral ulceration following healing was designated as recurrence. Results Some 766 ulcerated legs in 689 patients were assessed; 633 legs had an ABPI greater than 0·85. Venous duplex assessment revealed 8 per cent of these legs to have pure deep, 38 per cent pure superficial and 43 per cent a mixed reflux pattern. Ten per cent of legs had no demonstrable reflux. Some 131 of 241 limbs with pure superficial reflux underwent surgery. Healing rates at 12 and 24 weeks for all legs with an ABPI greater than 0·85 were 48 and 68 per cent respectively. Neither venous pattern nor surgery affected ulcer healing rates. Overall 1-, 2- and 3-year recurrence rates for venous ulcers were 25, 31 and 38 per cent respectively. The influence of venous reflux pattern and surgery on ulcer recurrence is summarized in Table. Conclusion Ulcer healing rates are not influenced by venous reflux pattern or surgery. Surgical correction of superficial venous reflux in the presence of chronic leg ulceration reduces long-term ulcer recurrence rates.

Quality of Life in Venous Ulceration: A Randomized Trial of Two Bandage Systems

Objective:To evaluate health-related quality of life (HRQoL) in a prospective randomised trial of patients suffering from venous ulceration, comparing the original four-layer bandage system with a new four-layer system (Profore).Design:Randomised prospective parallel groups trial.Setting:Community leg ulcer clinics within two trusts in England.Participants:Patients newly presenting for treatment suffering from chronic leg ulceration, with ankle–brachial pressure index (ABPI) &gt;0.8.Methods:Patients entering the trial were asked to complete the Nottingham Health Profile (NHP) at entry and after 12 and 24 weeks of treatment. Principal analysis was the comparison of final NHP scores analysed by ANOVA with baseline scores entered as a covariate.Results:In all, 231 of 232 patients who entered the trial completed the initial questionnaire, with 208 patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks, which were significantly greater in the 167 patients whose ulcers had healed compared with the 41 whose ulcers remained unhealed for the domains of Sleep (mean difference [ d] = 10.5, 95% CI 2.9 to 18.1, p = 0.007) and Bodily Pain ( d = 8.9, 95% CI 1.3 to 16.5, p = 0.023), with a large difference for Physical Mobility ( d = 5.0) which failed to achieve statistical significance (95% CI −0.5 to 10.6, p = 0.07) following adjustment for the baseline scores. There were similar mean scores between the 99 patients treated with the original bandage system and 109 treated with Profore for all domains of the NHP, the largest adjusted difference favouring Profore for Energy ( d = 3.7, 95% CI −3.8 to 11.2, p = 034).Conclusions:Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.

Cost effectiveness of community leg ulcer clinics: randomised controlled trial

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...

Community leg ulcer clinics and the effectiveness of care.

This literature review examines the effectiveness of community leg ulcer clinics in improving patient care

Community nurse education in leg ulcer management

An audit of a wound-care training project implemented in conjunction with an initiative to set up community leg ulcer clinics

Clinical audit and effective change in leg ulcer services.

An audit of clinical leg ulcer services was undertaken in South Bedfordshire and was followed by a process of implementation using research-based methods; a re-audit was conducted 18 months later. Using an adaptation of the Riverside model, patients were referred to community leg ulcer clinics. They were assessed using Doppler ultrasound; those with ABPI >0.8 were treated using a high-compression four-layer bandage system. Those with ABPI 0.6-0.8 were treated using reduced compression, and those with ABPI <0.6 were sent to their GP for referral for specialist opinion. In October 1993, the average cost of consumables for each patient was £8.53, and this rose to £10.14 in May 1995. However, patients treated in community clinics had a reduced cost of consumables of £7.91 compared with £10.78 for patients treated at home. There was also a corresponding reduction in weekly treatments and an overall reduction in nursing time to treat patients. In 111 patients (134 limbs) treated by high compression in the community clinics, cumulative percentage healing was 54% after 12 weeks and 68% after 24 weeks. Although these results were lower than those achieved in the Riverside project, much of the difference can be explained by the different patient populations and ulcer duration. The results support a system of care which offers rationalisation of service, staff training and research-based effective assessment and treatment.