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

Launched by FIRSTKIND LTD · Oct 10, 2023

Keywords

ClinConnect Summary

The Geko™ KM40C Hydrogel Skin Adhesion Trial is studying a new type of skin adhesive used with the geko™ XW-3 device, which helps treat leg ulcers by promoting wound healing. This trial aims to compare the new hydrogel, KM40C, to an older version, KM40A, to see if it sticks better to the skin while still being easy to remove and gentle on the skin. The trial is not yet recruiting participants, but it will involve adults over 18 who have a lower limb ulcer and healthy skin where the device will be applied.

To participate, individuals must be willing to give consent and be identified as needing geko™ treatment in addition to standard care for their wounds. However, those who are pregnant, using certain medical devices like a pacemaker, or are currently involved in other clinical trials may not be eligible. Participants can expect to help researchers understand how well this new adhesive works during treatment, potentially leading to better care options for leg ulcers in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult over 18.
• • 2. Patients who have a lower limb ulcer following evaluation by a Tissue Viability Nurse Specialist
• • 3. Intact healthy skin at the site of geko™ device application.
• • 4. Willing and able to give written informed consent
• • 5. Identified to receive geko™ treatment as an adjunct to standard care for wound management.
• Exclusion Criteria:
• • 1. Pregnancy or breast feeding
• • 2. Use of any other neuro-modulation device.
• • 3. Use of a cardiac pacemaker
• • 4. Current use of TENS in the pelvic region, back or legs
• • 5. Contraindication to geko ™ NMES treatment
• • 6. No response to geko ™ NMES i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
• • 7. Participation in any other clinical trial that may interfere with the outcome of either trial.