Isobar ECS v Sigvaris compression post ulcer healing (thermotrak)
Research type
Research Study
Full title
To compare comfort and compliance of Isobar Engineered Compression stockings with Sigvaris Compression Stockings in patients with healed venous leg ulcers requiring long term compression
IRAS ID
238426
Contact name
Keith Harding CBE
Contact email
Sponsor organisation
Advanced Therapeutic Materials Ltd
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Compression has been shown to reduce the risk of recurrence of venous ulcers. However comfort and compliance is a major issue, resulting in a large percentage of patients unable to tolerate compression. Recurrence rates are between 25-50%.\nIsobar engineered compression stockings(ECS) are made from a 3D scan of individual patients legs. The compression is produced to within 1mm Hg at any point on the limb. This should result in a more comfortable stocking which in turn should improve comfort and compliance and hence reduce ulcer recurrence rates.\nThis study will compare ECS with Sigvaris compression stockings to see if there is any difference in terms of comfort and compliance over 90 days. Secondary data will be collected on pressure profiles of all stockings at day 0, day 30, day 60 and day 90, health economic data to demonstrate any differences in treatment costs, and a temperature sensor will monitor skin temperature and wash cycles temperature
REC name
South West - Frenchay Research Ethics Committee
REC reference
18/SW/0048
Date of REC Opinion
14 Mar 2018
REC opinion
Further Information Favourable Opinion