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The MAVEN study compares the effectiveness of compression bandaging and the Juxta-Cures™ device in the management of people with venous ulceration.

Full title:

A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the Juxta Cures™ device in the management of people with venous ulceration: Feasibility Study

Short title:

Juxta Cures™ versus Bandaging for Venous Ulcers

Study objectives/aims:

The primary objective of the study is to determine the feasibility of running a randomised controlled trial comparing compression bandaging and the Juxta-Cures™ device. As part of the study secondary objectives will also be assessed.

Trial details:

Current treatment for venous ulceration involves bandaging therapy, which is replaced on a once or twice weekly basis. The Juxta-Cures™ device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging.

50 participants will be recruited (aim for study duration of 12-18 months) from a consultant or nurse-led clinic at Colchester Hospital and associated outlying clinics, and participants are randomised to receive either compression bandages or Juxta-Cures™. Following randomisation the participant will be reviewed in the leg ulcer clinic on a weekly basis whereby pressure monitoring will be conducted, dressings will be changed and ulcer measured with standard 1cm squared grids, and the Silhouette® 3D wound imaging system. The type of dressings applied will also be recorded as well as length of appointment.

At baseline, one month, three months and six months all participants will complete health related quality of life questionnaires. The planned study period for the randomised-control trial is 24 weeks for each participant.

Type of trial:

Randomised controlled trial (feasibility)

Sample size:

50 patients

Participating site:

Colchester Hospital University NHS Foundation Trust
Turner Road
Essex CO4 5JL

Study duration:

Three months set up, 12 months recruitment, three months data analysis (for trial participants – 24 weeks).


Trial set up: 01/08/2016 to 01/11/2016.
Planned recruitment start date: December 2016.

Chief investigator:

Mr Adam Howard

Trial sponsor:

Colchester Hospital University NHS Foundation Trust


Medi UK (Hereford, UK)

Contact details

Email: [email protected]

Further information for investigators