Evaluation of the efficacy of multilayer compression & UrgoStart Plus
Evaluation of the safety and effectiveness of the global treatment including multilayer compression therapy (Urgo KTwo®) in addition to an interactive wound dressing (UrgoStart® plus) in the management of venous leg ulcers
Colin E Davies
Gloucestershire Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Leg ulcers are notoriously difficult to treat with poor outcomes often reported. The majority of these ulcers are caused by a deficient venous return from the to lower leg and the mainstay in treatment is compression therapy and further venous treatments such as foam sclerotherapy. However, some ulcers still take many months to heal causing great suffering and reduced quality of life and great expense to the NHS.
More knowledge has been gained concerning the impact of protease (enzyme) activity in venous leg ulcers and high numbers of these could contribute to the non-healing state. UrgoStart Plus is an interactive dressing which has a protease modulating effect and has been shown to reduce proteases and improve healing. The CHALLENGE trial published by Meaume et al (2012) showed significant reductions in wound surface area following eight weeks of treatment with UrgoStart for venous leg ulcers and diabetic foot ulcer. However, there is no published data as yet evaluating impact on healing of venous ulcers at 12 weeks.
The present study aim is to evaluate the 12-week healing rates in patients with venous leg ulcers treated in a proven compression system using UrgoStart Plus as the wound contact layer. This can be compared with 12-week healing for a similar cohort of patients treated with the same compression system and a simple low adherent non-interactive dressing.
South West - Cornwall & Plymouth Research Ethics Committee
Date of REC Opinion
7 Aug 2023
Further Information Favourable Opinion