APRICOT study
Research type
Research Study
Full title
A pilot multi-centre, prospective, randomised, controlled crossover trial assessing patient and clinician impression of different two-layer compression therapy options
IRAS ID
252438
Contact name
Stacey Fisher
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Clinicaltrials.gov Identifier
IRAS252438, IRAS252438
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Chronic Venous Insufficiency is a common condition in the Western world. If not managed appropriately, it can lead to leg ulcers and the need for vascular surgery. It has a significant negative impact on patients’ lives and large cost implications for the NHS. Patient compliance with conservative management of CVI is essential to minimise the risk of complications; reduced or a lack of compliance with compression bandaging can rapidly worsen a patient’s condition. Over the years, compression bandaging has become more functional and comfortable for patients, but skin dryness, itching, sweating, and constriction of the bandaged leg(s) remains an issue. If these undesirable symptoms can be controlled then patient compliance may be better controlled. In this crossover design study, patients who qualify for compression bandaging treatment will trial a pair of two-layer bandage types, each for 4 weeks. It concerns the current market leader Coban 2 Lite (manufacturer is 3M) and a novel bandage called CoFlex TLC Calamine Lite (Andover Healthcare Inc). The latter has a primary skin-contact layer that is impregnated with Calamine, a product proven to soothe skin. The objective is to determine which bandage is best at controlling the earlier mentioned undesirable effects of wearing compression bandaging, such as itchiness. Thirty patients and ten treating clinicians will be asked their opinion, and clinical outcome measures will supplement their feedback.
REC name
Wales REC 6
REC reference
18/WA/0383
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion