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
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.
Summary of Results
The trial focused on testing how well the KM40C hydrogel sticks to the skin when used with the geko™ XW-3 neuromuscular electrical stimulation (NMES) device. A hydrogel adhesive is a gel-like substance designed to stick to the skin. It's made mostly of water and other materials that help it stay in place while being gentle on the skin. Hydrogels are often used in medical devices. The goal was to see if the adhesive strength of KM40C was as good as, or better than, the KM40A hydrogel, which is currently used clinically in the self-adhesive geko™ W3 device. The results show that the KM40C hydrogel sticks to the skin just as well as KM40A. Based on these findings, KM40C is suitable for use in the geko™ wound device.
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