Effectiveness of an acellular synthetic matrix in the treatment of hard‐to‐heal leg ulcers

Abstract

Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population. Despite improvements in wound care, some wounds will not heal and they present a significant challenge for patients and health care providers. A multi-centre cohort study was conducted to evaluate the effectiveness and safety of a synthetic, extracellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal venous or mixed leg ulcers. Primary effectiveness criteria were (i) reduction in wound size evaluated by percentage change in wound area and (ii) healing assessed by number of patients healed by end of the 12 week study. Pain reduction was assessed as a secondary effectiveness criteria using VAS. A total of 45 patients completed the study and no difference was observed between cohorts for treatment frequency. Healing was achieved in 35·6% and wound size decreased in 93·3% of patients. Median wound area percentage reduction was 70·8%. Over 50% of patients reported pain on first visit and 87·0% of these reported no pain at the end of the study. Median time to first reporting of no pain was 14 days after treatment initiation. The authors consider the extracellular synthetic matrix protein an effective and safe adjunct to standard care in the treatment of hard-to-heal leg ulcers.

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

“…The data sources included the intent‐to‐treat (ITT) population from the ASM plus SC study and the patients from the ITT populations treated with SC alone in the VenUS‐SC‐870 pooled SC dataset (Figure ) who met the key selection criteria: (i) ankle brachial pressure index ≥ 0·7; (ii) wound area at baseline ≤ 33·00 cm 2 ; (iii) wound duration at baseline ≥ 4 weeks; (iv) compression bandaging (multilayer high compression or short stretch high compression); and (v) patient has contact with a wound centre specialist on average once per week .…”

“…The phase II ASM plus SC study was a 12‐week prospective, multicentre effectiveness and safety study in 53 patients with chronic VLUs . It was conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients).…”

“…Mean age was 74·7 years (median = 76·0, Table ), mean wound duration 33·4 months (median = 10 months, Table ) and mean baseline wound area 7·4 cm 2 (median = 4·5 cm 2 , Table ). A total of 29 patients were male, and 24 were female (Table ) . There were 16 ulcers healed by the final trial visit in the phase II study.…”

“…The effectiveness of the ASM as an adjunct to standard care (ASM plus SC) has been evaluated in a single‐arm, prospective, non‐controlled, multicentre observational study using healing (100% reepithelialisation) and wound area reduction as end‐points . The purpose of our study was to compare healing times for VLUs based on their propensity to heal within 12 weeks and suitabilityfor multi‐layer, high‐compression therapy treated with SC in everyday practice in the UK to healing times of matched patient and ulcers treated with the ASM plus SC.…”

Innovation in compression: smart bandage technology to improve bandage application and monitoring

“…Indeed, the healing rates reported for VLU vary considerably. [9][10][11][12][13][14][15][16][17][18][19] Technical solutions to variability in application of bandages include printed ovals or rectangles that change to circles or squares at the correct bandage extension; markings on orthostatic devices that are matched to a scale; bandage application at full stretch. Direct measurement of interface pressure may be used on application and for monitoring 20 but pressure is usually measured at only one anatomic location.…”