Challenging passivity in venous leg ulcer care – the ABC model of management

The under‐utilisation of compression for venous leg ulcer (VLU) management translates into lost opportunities to heal wounds, improve patients' quality of life and maximise health care system efficiency. Although compression therapy is considered gold standard according to clinical guidelines, lack of clinician knowledge, unclear referral pathways, local unavailability of compression and patient unwillingness to receive compression, amongst other reasons, mean many candidates for compression do not receive appropriate treatment. This article presents a solution in the form of the ‘ABC model of VLU management, a simplified approach that challenges passivity in the current approach to VLU treatment and supports wider adoption of appropriate compression therapy systems.     

Evaluating the effectiveness of a self‐management exercise intervention on wound healing,functional ability and health‐related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial

Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence‐based care on the healing rates, functional ability and health‐related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12‐week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health‐related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention‐to‐treat) analysis to highlight the importance of adherence to an exercise intervention. Intention‐to‐treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health‐related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health‐related quality of life), intention‐to‐treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self‐management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.     

Clinical efficacy of a silver‐releasing foam dressing in venous leg ulcer healing: a randomised controlled trial

Biatain and Biatain‐Ag are two identical wound dressings except the fact that Biatain‐Ag releases silver. In the present multinational double‐blinded randomised controlled trial the effect of the two dressings were compared for treatment of venous leg ulcers. A total of 181 patients were treated for 6 weeks with either Biatain or Biatain‐Ag followed by 4 weeks treatment with Biatain. Biatain‐Ag showed superior performance in relative wound area reduction after 6 weeks treatment and the estimated treatment difference increased after 10 weeks indicating that the effect of silver continues at least for 4 weeks after treatment. A subgroup of the patients differed significantly from the others with respect to parameters associated with a poor healing prognosis; patients were older, had significant history of venous thrombosis, larger ulcers with longer duration and more often recurrent. For this subgroup of patients Biatain‐Ag showed significant (P < 0·05) better performance in terms of relative ulcer area reduction and healing rate. In conclusion, this study suggests the superior performance of Biatain‐Ag compared with the non silver‐releasing dressing Biatain in particular for patients having ulcers associated with a poor healing prognosis.     

Low‐grade elastic compression regimen for venous leg ulcers – an effective compromise for patients requiring daily dressing changes

Venous leg ulcers (VLUs) affect millions of patients worldwide and are a tremendous financial burden on our health care system. The hallmark of venous disease of the lower extremities is venous hypertension, and compression is the current mainstay of treatment. However, many patients are non‐compliant, partly because of the complexity of the dressings and the difficulties with application and removal. The aim of our study was to test an effective compression dressing regimen for patients with VLUs who require changing the ulcer primary dressing twice daily. We used two layers of a latex‐free tubular elastic bandage for compression. The primary endpoint of our study was increased wound‐healing rate and our secondary endpoint was complete wound closure. All active study subjects had positive healing rates at week 4 and week 8. Two subjects achieved complete wound closure by week 8. We conclude that compression with a latex‐free tubular elastic bandage can be safely used in patients with VLUs requiring frequent dressing changes. This type of compression allows for daily inspection of wounds, dressing changes at home, flexibility in the context of clinical trials, and is a compromise for patients who are intolerant to compression dressings.     

Combined use of fenestrated‐type artificial dermis and topical negative pressure wound therapy for the venous leg ulcer of a rheumatoid arthritis patient

We report a case of circumferential venous leg ulcer in a rheumatoid arthritis patient. Mesh skin grafting was performed in another hospital, but the graft failed and the patient was referred to our hospital. This ulcer was treated by the combination therapy of a fenestrated‐type artificial dermis with negative pressure wound therapy (NPWT) and secondary mesh grafting using our ‘grip tape technique’. NPWT was started at ?100 mmHg and continued until the formation of dermis‐like tissue. A section stained using haematoxylin and eosin and an anti‐αSMA (α smooth muscle actin) immunohistological section of the biopsy from dermis‐like tissue showed an abundant infiltration of fibroblasts and capillary formation beneath the fenestration of the silicone sheet. Threefold mesh skin grafting was subsequently performed and it was taken up completely. The fenestrated‐type artificial dermis in combination with NPWT produced good results without infection in the treatment of complex wounds. In addition, our ‘grip tape technique’ was useful to apply polyurethane foam to the entire surface of the lower leg.     

Variations in study outcomes relative to intention‐to‐treat and per‐protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention‐to‐treat (ITT) and/or the per‐protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi‐layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n = 109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12 weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant; P = 0.0473, ITT and P = 0.0128, PP. The Kaplan‐Meier plot of time to heal within 12 weeks for the ITT and PP populations demonstrated a superior wound‐healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.     

Translation,cross‐cultural adaptation and validation of the “Cardiff wound impact schedule,” a wound‐specific quality of life instrument,to the native Spanish of Mexican patients

The aim of this study was to translate into Mexican Spanish, cross‐culturally adapt and validate the wound‐specific quality of life (QoL) instrument Cardiff wound impact schedule (CWIS) for Mexican patients. This instrument went through the full linguistic translation process based on the guidelines of Beaton et al (Beaton DE, Bombardier C, Guillemin F, Ferraz MB, Guidelines for the process of cross‐cultural adaptation of self‐report measures, Spine Phila Pa, 1976, 2000, 318‐391). We included a total of 500 patients with chronic leg ulcers. The expert committee evaluated the Face validity and they agreed unanimously that the instrument was adequate to assess the QoL of these patients, covering all relevant areas presented by them. The content validity index obtained was of 0.95. The construct validity demonstrated moderately significant correlations between related sub‐scales of CWIS and SF‐36 (P = .010 to P < .001). The instrument was able to discriminate between healed and unhealed ulcers. The instrument obtained an overall Cronbach's alpha of .952, corresponding to an excellent internal consistency (.903‐.771 alpha range for domains). The CWIS can be appropriately used to assess the health‐related QoL of Mexican patients with chronic leg ulcers.     

Mirabegron 50 mg once‐daily for the treatment of symptoms of overactive bladder: An overview of efficacy and tolerability over 12 weeks and 1 year

The aim of the present review article was to summarize the efficacy and tolerability for mirabegron 50 mg over 12 weeks and 1 year versus placebo (SCORPIO) or tolterodine ER 4 mg (SCORPIO and TAURUS). After a 2‐week placebo run‐in, adults with overactive bladder symptoms for ≥3 months were randomized if, during a 3‐day micturition diary period before baseline, they had an average of ≥8 micturitions/24 h and ≥3 urgency episodes. Efficacy end‐points were change from baseline to each study visit and final visit in incontinence, micturitions, volume voided/micturition, urgency incontinence, urgency (grades 3 or 4), level of urgency and nocturia. Additional secondary efficacy variables included patient‐reported outcomes. Safety variables included changes in treatment‐emergent adverse events and vital signs. For SCORPIO, statistically significant improvements from baseline in efficacy variables and patient‐reported outcomes were seen with mirabegron versus placebo from week 4, and were maintained over time. For TAURUS, numerical improvements in efficacy were evident from month 1, and were maintained throughout 12 months. Treatment‐emergent adverse events incidence was similar between groups, except for dry mouth, which was reported by fourfold (SCORPIO) and threefold (TAURUS) more patients taking tolterodine than mirabegron. Mirabegron 50 mg for 12 weeks was associated with statistically significant improvements in objective measures of efficacy and patient‐reported outcomes. At final visit, improvements with mirabegron 50 mg were statistically greater versus placebo. The efficacy profile of mirabegron 50 mg appears to be maintained over 12 months.