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

Firstkind

Status: Not yet enrolling

Conditions: Leg Ulcer

Treatments: Device: geko™ X-W3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06084546

FSK-R&D-002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard care with geko™ W3 device

No Intervention group

Description:

Current geko™ device incorporating hydrogel adhesive designated KM40A

Standard care with geko™ X-W3

Active Comparator group

Description:

Next generation geko™ device incorporating new hydrogel adhesive designated KM40C

Treatment:

Device: geko™ X-W3