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

Leg Ulcer Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084546
• Other study ID #: FSK-R&D-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Firstkind Ltd
• Contact: Marie-Therese Targett
• Phone: 07340903377
• Email: marie-therese.targett[@]firstkindmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Central London Community Health Care NHS Trust	London
United Kingdom	Norfolk Community Health and Care NHS Trust	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM40A	Self reported - how well did the geko™ device stick to the patients leg? Scale 1-5, Lowest score indicates best adhesion.	28 days
Secondary	Incidence of Adverse Events	Reporting of the incidence of adverse events , incidence of serious adverse events, incidence of study treatment related adverse events, and the incidence of device related adverse events	28 days