PEACH trial
Research type
Research Study
Full title
Prospective Evaluation of Applied ‘Lite’ Compression for leg ulcer Healing, a pragmatic, multi-centre randomized controlled non-inferiority trial
IRAS ID
280418
Contact name
Jane Todhunter
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
ISRCTN Number
ISRCTN37496076
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Leg ulcers are a challenging condition to manage and treat; there is a high risk of the wounds becoming chronic, infected and needing surgical intervention. Apart from having a significant negative impact on patients’ lives, it is also an economic burden to the National Health Service. Compression bandaging is the main treatment option for leg ulcers, and patient compliance with this therapy is key to maximise chances of wound healing and minimise the risk of complications. In recent years, compression bandaging has become more functional and comfortable for patients, but in a recent study we showed that itching and other undesirable symptoms related to having a leg bandaged are still an issue. Initial data has demonstrated that a novel bandage called Andoflex TLC Calamine Lite (Milliken Healthcare Inc) reduces discomfort and possibly accelerates leg ulcer healing. In this pragmatic randomised controlled trial, leg ulcer patients who may benefit from reduced compression therapy will be allocated by chance to one of two bandages: AndoFlex TLC Calamine Lite or 3M’s Coban 2 Lite. The aim is to determine how effective each bandage is at promoting leg ulcer healing over a period of 12 weeks. In total, 72 patients are planned to be enrolled and for clinical reasons these patients cannot be administered full compression bandaging and are hence administered reduced (or ‘Lite’) compression bandaging. Outcome measures will be wound healing rates and also patient reported quality of life.
REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0158
Date of REC Opinion
24 Nov 2022
REC opinion
Favourable Opinion