Evaluation of Artificial Dermis for the Treatment of Leg Ulcers: Clinical Outcomes From an Exploratory Study

ABSTRACT

Chronic leg ulcers present a significant clinical challenge due to their prolonged healing time and high recurrence rates. This prospective, multi-centre, non-randomised, observational study investigated the efficacy of a dermal regeneration template in improving skin graft integration for chronic leg ulcer treatment. Thirty patients were enrolled, with a control group receiving only skin grafts to evaluate the additional benefits of the template. Patients were assessed for pain levels, healing rates, wound retraction, pruritus, dressing type, analgesic use, complications, surgeon-evaluated wound recovery using the Vancouver scale, quality of life through the EuroQol questionnaire and photographic wound documentation. At 18 months, 70.0% of patients achieved at least a 50% reduction in wound surface area and 56.7% experienced complete wound closure. Significant improvements were observed in pain and discomfort (p = 0.0125), mobility (p = 0.0267), pain levels (p = 0.0340), vascularity (p = 0.0275) and overall wound reduction (p = 0.0368). The control group demonstrated lower wound reduction and complete healing rates, reinforcing the superior effectiveness of the dermal regeneration template in combination with skin grafting. This study highlights the potential of this approach to accelerate wound healing, reduce patient discomfort and enhance quality of life compared to traditional skin grafting alone.