Engineered compression stockings Vs two layer compression bandaging
Research type
Research Study
Full title
Comparing current standard compression bandaging with Isobar 3D bespoke manufactured compression hosiery in the treatment of venous leg ulcers.
IRAS ID
221171
Contact name
James Hampton
Contact email
Sponsor organisation
Advanced Therapeutic Materials Limited
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
This study is designed to investigate potential benefits in terms of healing rates and cost of using 3D bespoke compression hosiery as an alternative to current 2 Layer Compression Bandaging (2LB). Patients will be allocated to either current standard treatment or Isobar 3D bespoke compression, and will be followed up using 3D volumetric measurements of ulcer size.
The groups are as follows:
1. Patients with current venous leg ulcers wearing 3D engineered compression stockings versus:
2. Patients with current venous leg ulcers wearing 2 layer compression bandagingIn addition to volumetric ulcer healing rates we will also use a questionnaire to ask patients to tell us how comfortable their treatment was, and if they experience any complications or difficulties with their treatment. The aim is to determine whether the patients find 3D engineered compression stockings more acceptable, less acceptable, or no different than conventional treatment.
The final part of the study is to perform a cost benefit analysis to determine whether or not 3D engineered compression stockings are a viable alternative to 2LB in terms of savings in dressings and expensive skilled nurse time.
REC name
Wales REC 4
REC reference
17/WA/0312
Date of REC Opinion
10 Oct 2017
REC opinion
Favourable Opinion