The MAVEN Study
Research type
Research Study
Full title
A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the Juxta-CuresTM device in the MAnagement of people with VEnous ulceratioN: Feasibility Study: The MAVEN study
IRAS ID
194055
Contact name
Adam Howard
Contact email
Sponsor organisation
Colchester Hospital University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Leg ulcers are often caused by increased pressure in the leg due to incompetent veins. These venous ulcers are a major burden on the NHS, affecting 600,000 patients per year and costing the NHS £2.3-3.1 billion per year. The mainstay of treatment is compression bandaging. This is done 2-3 times per week, and is expensive due to the price of bandages and time required to apply them. The Juxta-CuresTM device is a reusable compression device tailored for individual patients. It is removable, adjustable, quick to apply, and lasts for 6 months. It typically costs half to one-third the price of compression bandages, and due to its removability, this allows patients to continue with normal daily activities, and wear their own shoes. The juxta-CuresTM device also provides more consistent pressure to the lower leg, which in theory should aid in ulcer healing.
This feasibility study aims to compare compression bandaging to the Juxta-CuresTM device, and has been developed with our patient focus group. The study will compare treatment costs, patient experience (quality of life) and ulcer size throughout the 6 months of the trial. 50 participants will be allocated to either compression bandaging or the Juxta-CuresTM device, and they will be reviewed every 1-2 weeks in the leg ulcer clinic.
The feasibility study will be conducted at Colchester Hospital only, with the intention to both publish these results, and finalise designs for a national study run alongside the Vascular and Endovascular Research Network, which is a collaborative set up by vascular surgeons in training to help facilitate research across multiple hospitals.
Venous leg ulcer treatment has remained largely unchanged over decades. This trial aims to compare traditional treatment to a newer device, to determine which treatment is superior in terms of cost, patient experience, and ulcer treatment.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0271
Date of REC Opinion
18 Aug 2016
REC opinion
Further Information Favourable Opinion