geko KM40C Hydrogel Skin Adhesion Trial
Research type
Research Study
Full title
Evaluation of the Adhesive Strength of an Improved Skin Adhesive Hydrogel Formulation Designated KM40C incorporated in the geko™ X-W3 Neuromuscular Electrical Stimulator (NMES) Device in Patients with Lower Limb Ulcers.
IRAS ID
333161
Contact name
Agnes Collarte
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
The geko™ neuromuscular electrostimulation device or geko™ NMES device for short, is a wearable medical device which uses an adhesive called a hydrogel to fix the device to the skin. The hydrogel has to be able to be able to stick well to the skin, provide good contact for the electrodes and also be easy to remove. The purpose of this study is to test the performance of a new hydrogel used in the geko™ X-W3 NMES device, so that it can be compared to the hydrogel already tested and incorporated in the geko™ W3 neuromuscular electrostimulation device which is currently being used to treat patients as an adjunct to standard care for wound management. Participants will be asked to wear one of these device as part of their treatment for their leg ulcer, in addition to their standard care. 30 study patients will be recruited from two hospitals in the UK to participate in this study. The study will help us to determine if the new hydrogel is as good as if not better than the one already in use for ulcer patients.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0257
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion