NCT06084546

Geko™ KM40C Hydrogel Skin Adhesion Trial (XW-3)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Firstkind Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hydrogel KM40C is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ XW-3 neuromuscular electrical stimulation (NMES) device. KM40C has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. KM40C has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ NMES treatment as an adjunct to standard care for wound management. The objective of this trial is to evaluate the skin adhesive performance of hydrogel KM40C during clinical use of the geko™ XW-3 NMES device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel KM40A incorporated in the self-adhesive geko™ W3 device which is currently in use clinically. Both devices are indicated for use to promote wound healing, the geko™ W3 NMES device is UKCA and CE marked whereas the geko™ X-W3 is UK CA marked only.

Conditions

• Leg Ulcer

Interventions

Type	Name	Description
DEVICE	geko™ X-W3	The geko™ X-W3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ W3 device and the new geko™ XW-3 device is the adhesive used to attach each device to the skin.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-10-16
• Last updated: 2023-10-16

Locations

2 sites across 1 country: United Kingdom