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
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.Lay summary of study results: What was the PEACH research study about?
The research study was called the PEACH trial (Prospective Evaluation of Application of Compression for wound Healing). Compression bandaging is the recognised standard to treat leg ulcers, because it can help in promoting circulation and lymph drainage of the leg. It is important to try and use the most effective bandaging.
The aim of the study was to find out if there is a difference in effectiveness of two different compression bandage brands for the treatment of leg ulcers. The two devices were Andoflex TLC Calamine Lite and Coban2 Lite. Both compression bandages use a similar two-layer method and apply similar pressure to the wrapped leg.
In the last year, we invited patients with a leg ulcer (wound) who presented in vascular clinics in North Cumbria. Patients were in the study for up to 12 weeks. At baseline (week ‘0’) and then mid-way through at week 6 and week 12 the ulcer size was measured, and the status of it determined (healed or not healed). A total of 78 patients took part, and by chance each patient was allocated to treatment with one of the two compression bandages.
What did we find?
The main finding was that there is no significant difference in effectiveness of Andoflex TLC Calamine Lite and Coban2 Lite. In other words, both compression bandages perform to a similar standard.
In this study, around 50% of leg ulcers had healed by the end of the trial period (after 12 weeks of treatment). This was achieved with both types of compression bandage. The exact percentage was 53% for Andoflex TLC Calamine Lite and 45% for Coban2 Lite. No major complications with use of either bandage brand were observed. No difference in levels of itchiness or other discomfort were seen between the two different compression bandage products either.
In conclusion, nurses and patients should be able to make a decision which of these two compression bandage products to use. From previous research we know that some patients may prefer one brand over the other in terms of comfort.REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0158
Date of REC Opinion
24 Nov 2022
REC opinion
Favourable Opinion