Non‐contact low‐frequency ultrasound therapy compared with UK standard of care for venous leg ulcers: a single‐centre,assessor‐blinded,randomised controlled trial

‘Hard‐to‐heal’ wounds are those which fail to heal with standard therapy in an orderly and timely manner and may warrant the use of advanced treatments such as non‐contact low‐frequency ultrasound (NLFU) therapy. This evaluator‐blinded, single‐site, randomised controlled trial, compared NLFU in addition to UK standard of care [SOC: (NLFU + SOC)] three times a week, with SOC alone at least once a week. Patients with chronic venous leg ulcers were eligible to participate. All 36 randomised patients completed treatment (17 NLFU + SOC, 19 SOC), and baseline demographics were comparable between groups. NLFU + SOC patients showed a −47% (SD: 38%) change in wound area; SOC, −39% (38%) change; and difference, −7·4% [95% confidence intervals (CIs) −33·4–18·6; P = 0·565]. The median number of infections per patient was two in both arms of the study and change in quality of life (QoL) scores was not significant (P = 0·490). NLFU + SOC patients reported a substantial mean (SD) reduction in pain score of −14·4 (14·9) points, SOC patients' pain scores reduced by −5·3 (14·8); the difference was −9·1 (P = 0·078). Results demonstrated the importance of high‐quality wound care. Outcome measures favoured NLFU + SOC over SOC, but the differences were not statistically significant. A larger sample size and longer follow‐up may reveal NLFU‐related improvements not identified in this study.     

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.     

A prospective,multicentre, randomised controlled study of human fibroblast‐derived dermal substitute (Dermagraft) in patients with venous leg ulcers

This was an open‐label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast‐derived dermal substitute (HFDS) plus four‐layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12 weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty‐four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P = 0·235). For ulcers ≤ 12 months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12 weeks (P = 0·029). For ulcers ≤ 10 cm², complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P = 0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.     

Safety and performance evaluation of a next‐generation antimicrobial dressing in patients with chronic venous leg ulcers

The objective of this study was to investigate the safety and performance of AQUACEL? Ag+ dressing, a wound dressing containing a combination of anti‐biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL? Ag+ dressing, followed by management with AQUACEL? wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL? Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non‐treatment‐related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL? Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm.     

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.     

Education in people with venous leg ulcers based on a brochure about compression therapy: A quasi‐randomised controlled trial

Brochures are a useful supplement to patient education. There is increasing evidence that they are an effective medium to support patient satisfaction, adherence, and empowerment. This study aims to produce reliable data on how much patients with venous leg ulcer (VLU) may profit from a brochure that focuses on VLU and on measures and aims of the related compression therapy. The evaluation took part from October 2018 until March 2019 and included 136 patients with VLU and related compression therapy. They were randomly sorted into a case group and a control group of 68 patients each. The case group received a brochure about venous disease and compression therapy and filled in a questionnaire after reading. The questions ranged from basic knowledge about VLU and compression therapy to aspects of self‐care. The control group answered the same questions without previous reading of the brochure. The results show that in almost every aspect, the patients in the case group were better informed about their diseases, the compression therapy, and how they may support the measures adequately. This study suggests that patients with VLU may profit from a brochure that explains their disease and the related compression therapy. Better knowledge and understanding may strengthen their empowerment and adherence.     

Treatment of chronic diabetic lower leg ulcers with activated protein C: a randomised placebo‐controlled,double‐blind pilot clinical trial

Lower leg ulcers are a serious and long‐term complication in patients with diabetes and pose a major health concern because of the increasing number of patients diagnosed with diabetes each year. This study sought to evaluate the clinical benefit of topical activated protein C (APC) on chronic lower leg ulcers in patients with diabetes. Twelve patients were randomly assigned to receive either APC (N = 6) or physiological saline (placebo; N = 6) in a randomised, placebo‐controlled, double‐blind pilot clinical trial. Treatment was administered topically, twice weekly for 6 weeks with final follow‐up at 20 weeks. Wound area was significantly reduced to 34·8 ± 16·4% of week 0 levels at 20 weeks in APC‐treated wounds (p = 0·01). At 20 weeks, three APC‐treated wounds had completely healed, compared to one saline‐treated wound. Full‐thickness wound edge skin biopsies showed reduced inflammatory cell infiltration and increased vascular proliferation following APC treatment. Patient stress scores were also significantly reduced following APC treatment (p < 0·05), demonstrating improved patient quality of life as assessed by the Cardiff Wound Impact Questionnaire. This pilot trial suggests that APC is a safe topical agent for healing chronic lower leg ulcers in patients with diabetes and provides supporting evidence for a larger clinical trial.     

The efficacy of topical royal jelly on healing of diabetic foot ulcers: a double‐blind placebo‐controlled clinical trial

Foot ulcers are major sources of morbidity in individuals with diabetes mellitus. As royal jelly (RJ, a worker honey bee product) contains enzymatic, antibacterial and vasodilative properties, it can potentially help in healing of diabetic foot ulcers (DFUs). This study aimed to evaluate the efficacy of topical RJ on healing of DFUs. Diabetic patients with foot ulcers who were referred to us at Khorshid Hospital, Isfahan, Iran, were managed by offloading, infection control, vascular improvement and debridement (if required). Then, all ulcers were randomly selected to receive either 5% sterile topical RJ or placebo on their total surface area. Patients were followed for 3 months or until complete healing. Twenty‐five patients (6 females and 19 males) and a total of 64 ulcers were included and randomly allocated to case or control group (32 per group). Four ulcers were excluded and 60 ulcers included in the final analysis. Healing parameters including depth, length and width reduction rate, duration of complete healing and incidence of complete healing did not show any significant difference (P = 0·69, 0·95, 0·7, 0·74 and 0·6, respectively) between groups. We did not observe any side effect of topical RJ application. This study could not confirm any significant superiority of 5% topical RJ over placebo for the treatment of DFUs.     

Adaptive compression therapy for venous leg ulcers: a clinically effective,patient‐centred approach

A prospective, randomised, 12‐week study was performed to evaluate the efficacy and tolerability of two compression methods for venous leg ulcers (VLUs); a new adaptive compression therapy (ACT) system, combining intermittent and sustained pneumatic compression (n = 38) and a conventional four‐layer bandage system (n = 52). Primary outcomes were ulcer healing and safety. Secondary outcomes were comfort, compliance, ulcer pain, patient‐perceived product performance and quality of life. Ulcer healing rate was similar (31·6% versus 42·3%, respectively, P = 0·30) between the treatments. Adverse events and patient‐rated comfort were also similar. Average daily usage for the dual system was 10·5 and 1·8 hours in the sustained and intermittent modes, respectively, representing its use during 71% of waking hours. Predicted final ulcer pain was also similar (P = 0·68). Performance was subjectively better for adaptive compression and significantly higher for exudate management (P = 0·04), skin protection (P < 0·001), removal ease (P = 0·0007), bathing (P < 0·0001) and sleep comfort (P = 0·0405). The adjusted final quality‐of‐life score was 0·1025 higher for adaptive compression (P = 0·0375). Subjects with healed ulcers attained higher final scores than unhealed subjects (P = 0·0004). This study provides evidence that ACT is comparably efficacious to successfully heal VLUs compared with four‐layer bandage management but is better accepted and achieves higher patient‐reported quality‐of‐life scores in these challenging patients.     

Quality of life psychosocial characteristics in Greek patients with leg ulcers: a case control study

Chronic leg ulcers are a public health problem that can have a significant impact on the patient's physical, socioeconomic and psychological status. The aim of this study is to evaluate the quality of life, anxiety and depression, self‐esteem and loneliness in patients suffering from leg ulcers. A total of 102 patients were enrolled in the study. The quality of life, anxiety and depression, self‐esteem and loneliness of the patient were assessed using the Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Scale (HADS), Rosenberg's Self‐esteem Scale (RSES) and the UCLA Loneliness Scale (UCLA‐Version 3), respectively. The mean DLQI score was 13·38 ± 2·59, suggesting a serious effect on the quality of life of patients. Those with leg ulcers had statistically significant higher scores according to the HADS‐total scale (P = 0·031) and HADS‐anxiety subscale (P = 0·015) compared with healthy volunteers. Moreover, a statistically significant difference was found between the two groups concerning the UCLA‐scale (P = 0·029). Female patients presented with a higher score of anxiety (P = 0·027) and social isolation (P = 0·048), and worse quality of life (P = 0·018) than male patients. A severe quality of life impairment was documented, reflecting a significant psychosocial impact on patients with leg ulcers.     

Evaluation of a muscle pump‐activating device for non‐healing venous leg ulcers

This evaluation involves an innovative muscle pump‐activating device (geko™) as an adjunctive therapy with best practices for non‐healing venous leg ulcers (VLUs). Stimulating the common peroneal nerve (at the fibular head), the geko™ device creates a response that acts as foot and calf muscle pumps, increasing venous, arterial and microcirculatory flow. The aim was to evaluate and determine if the geko™ is effective in this population and if it should be added to the medical supply formulary. In all, 12 patients with 18 recalcitrant VLUs (defined as less than 30% reduction in wound size in 30 days with best practices) in two community settings in Ontario consented to the evaluation and were treated with the geko™ for up to 20 weeks. A total of 44% of wounds healed, and 39% decreased in size. One patient non‐adherent with the geko™ and best practices had deterioration in his or her wounds. With the patients as their own control, the mean weekly healing rate with the geko™ was 9·35% (±SD 0·10) compared to 0·06% (±SD 0·10) prior to baseline, which was statistically significant (P < 0·01). Three patients not in optimal therapy increased compression due to decreased pain, further enabling healing. This study was not a randomised investigation, although the patients acted as their own controls. A pragmatic evaluation reflects the reality of the community sector; in spite of best practices or evidence‐based care, therapy is not uniformly applied, with some participants unable to tolerate or indeed comply with optimal compression therapy. Rash occurred under the devices in 7 of 12 (58%) patients. One patient stopped the device due to rash, while another had to take breaks from using the device. Subsequently, the manufacturer (FirstKind Ltd) has developed a new device and protocol specific to the requirements of wound therapy to minimise this response. This small case series demonstrated the highly significant effectiveness of the geko™ device in these hard‐to‐heal VLUs. Further evaluations to determine dose and patient selection criteria are underway.     

Efficacy and cost‐effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings

The aim of this study was to determine the efficacy, safety and cost‐effectiveness of an octenidine‐based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound‐phase‐adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound‐phase‐adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3–5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1–3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost‐effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing.     

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.     

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicentre, randomised, double-blind clinical investigation of 122 patients compared two moist wound-healing dressings, a non adhesive foam dressing with ibuprofen (62 patients randomised to Biatain-Ibu non adhesive, Coloplast A/S) with a non adhesive foam without ibuprofen (60 to Biatain non adhesive). The ibuprofen-foam was regarded successful, if the pain relief on a 5-point verbal rating scale was higher than the comparator without compromising safety, including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 and days 43-47. The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group compared with the comparator on days 1-5, with a quick onset of action (P < 0.05). The patients in the ibuprofen-foam group had a significant (P < 0.05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%). Women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with increasing initial pain intensity and increasing wound size. Wound healing was similar in the ibuprofen-foam group to that of the comparator group. No difference in adverse events between placebo and local sustained release of low-dose ibuprofen was observed in this study. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters. The full report of this study will be published in Wound Repair and Regeneration.     

Compression strapping: the development of a novel compression technique to enhance compression therapy and healing for 'hard-to-heal' leg ulcers

Non healing wounds of the lower limb continue to be a significant issue for both practitioners and patients. Failure of gold-standard management demands a creative response. This article describes the development of a novel and intuitive strapping technique overlying the compression bandage that appears to have an influence in healing complex lower limb ulcers. A retrospective audit of 17 patients with 25 ulcers allows further analysis and discussion. The strapping technique uses cohesive inelastic compression bandaging; narrow strips of bandages are layered in a fan distribution over the ulcer and oedema. This approach seems to offer an intuitive response to these complex wounds, allowing management to be tailored to the site of the ulcer and oedema. Tolerance for this less bulky compression therapy regime is excellent, thereby aiding healing and reducing all costs associated with non healing leg ulcers.     

A pilot multi‐centre prospective randomised controlled trial of RECELL for the treatment of venous leg ulcers

Venous leg ulcers (VLUs) have a significant impact on approximately 3% of the adult population worldwide, with a mean NHS wound care cost of £7600 per VLU over 12 months. The standard care for VLUs is compression therapy, with a significant number of ulcers failing to heal with this treatment, especially with wound size being a risk factor for non‐healing. This multicentre, prospective, randomised trial evaluated the safety and effectiveness of autologous skin cell suspension (ASCS) combined with compression therapy compared with standard compression alone (Control) for the treatment of VLUs. Incidence of complete wound closure at 14 weeks, donor site closure, pain, Health‐Related Quality of Life (HRQoL), satisfaction, and safety were assessed in 52 patients. At Week 14, VLUs treated with ASCS + compression had a statistically greater decrease in ulcer area compared with the Control (8.94 cm² versus 1.23 cm², P = .0143). This finding was largely driven by ulcers >10 to 80 cm² in size, as these ulcers had a higher mean percentage of reepithelialization at 14 weeks (ASCS + compression: 69.97% and Control: 11.07%, P = .0480). Additionally, subjects treated with ASCS + compression experienced a decrease in pain and an increase in HRQoL compared with the Control. This study indicates that application of ASCS + compression accelerates healing in large venous ulcers.     

A randomised controlled 8-week crossover clinical evaluation of the 3M Coban 2 Layer Compression System versus Profore to evaluate the product performance in patients with venous leg ulcers

This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P < 0.05). Patients had a strong preference for the two-layer system (72%) than the four-layer system (22%), with 6% having no preference. In conclusion, the two-layer system exhibited significantly less bandage slippage than the four-layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two-layer system and potentially impacted patients' HRQoL.     

The silver-releasing foam dressing, Contreet Foam, promotes faster healing of critically colonised venous leg ulcers: a randomised, controlled trial

The study compared the effect of a sustained silver-release foam dressing (Contreet Foam) with a foam dressing (Allevyn Hydrocellular) without added silver in critically colonised venous leg ulcers with delayed healing. The study was a multicentre, open, randomised, controlled study lasting for 4 weeks. Ulcer area and healing were assessed weekly. Odour, maceration, absorption capacity and leakage were evaluated at dressing changes. All adverse events were recorded. One hundred and twenty-nine patients were included (Contreet Foam: 65, Allevyn Hydrocellular: 64). The two groups were comparable in all respects. After 4 weeks, there was a significantly greater reduction in ulcer area in the Contreet Foam group (45%) than in the Allevyn Hydrocellular group (25%). After 1 and 4 weeks, odour was present in significantly less of the ulcers in the Contreet Foam group (17% and 19%, respectively) compared with the Allevyn Hydrocellular group (47% and 39%, respectively) and at the final visit there were significantly fewer leakages in the Contreet Foam group (19%) compared with the Allevyn Hydrocellular group (49%). Also, less maceration was observed after 1 and 4 weeks in the Contreet Foam group (34% and 37%, respectively) compared with the Allevyn Hydrocellular group (55% and 48%, respectively). The occurrence and cause of adverse events were equally distributed between the study groups. The present study provides evidence of the superior performance of the silver-releasing dressing, Contreet Foam, compared with a traditional moist foam wound healing dressing in the treatment of critically colonised, chronic venous leg ulcers. The results of this randomised, controlled study suggest an important role of sustained silver-releasing dressings in the treatment of critically colonised chronic wounds.     

A single‐arm trial indirect comparison investigation: a proof‐of‐concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof‐of‐concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score‐matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi‐layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow‐up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan–Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ² 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non‐healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.