Adjustable Compression Device
Research type
Research Study
Full title
A randomised, controlled, clinical study to compare a new adjustable compression system, with a commonly used two layer bandage, in patients with venous leg ulcers
IRAS ID
186501
Contact name
Samantha Needham
Contact email
Sponsor organisation
3M Deutschland GmbH
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
The key to successful management of venous leg ulcers is compression. Multi-component bandaging systems are proven to be effective but require skill and knowledge to apply and are prone to loosen and slip, quickly reducing their effectiveness drastically. It is not possible to wash underneath the bandages, unless they are being replaced, and they cause difficulties with clothing and/or footwear. Compression stockings are another therapy, often used with small uncomplicated ulcers and by those who wish to self care, however, care must be taken not to cause harm to the wound or surrounding skin during application and removal. A two-component system is safer and easier to use than a single stocking, the first holds the dressing in place and the second adds up the pressure and can be removed at night. The optimal system would combine the advantages of bandages and stockings, be easy to apply, maintain optimal compression, allow for self application and be easily removable at night and for washing. The study sponsor has developed a new adjustable compression system consisting of 2 components; a low-compression stocking and a customisable compression sleeve that follows the proven principle of compression. The system is designed to empower patients and their carers and to allow them to play a greater part in the management of their ulcer. After initial fitting the device can be self-applied and patients are able to wear their normal shoes and clothing it is easily removable for washing. This study will evaluate the therapeutic effect of the study device on venous leg ulcers when compared to the comparator , a two layer compression bandage. The ulcers will be observed at regular clinic visits with device-related assessments at 1 week intervals over a 12 week treatment period. The target recruitment is 44 subjects, 22 will be randomised to each group.
REC name
Wales REC 3
REC reference
15/WA/0357
Date of REC Opinion
9 Oct 2015
REC opinion
Favourable Opinion