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

NCT06084546 | Unknown

• 1 other identifier: FSK-R&D-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

geko; NMES

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Adverse Events

  28 days

Study Arms (2)

Standard care with geko™ W3 device

NO INTERVENTION

Current geko™ device incorporating hydrogel adhesive designated KM40A

Standard care with geko™ X-W3

ACTIVE COMPARATOR

Next generation geko™ device incorporating new hydrogel adhesive designated KM40C

Device: geko™ X-W3

Interventions

geko™ X-W3 DEVICE

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.

Standard care with geko™ X-W3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult over 18.
• Patients who have a lower limb ulcer following evaluation by a Tissue Viability Nurse Specialist
• Intact healthy skin at the site of geko™ device application.
• Willing and able to give written informed consent
• Identified to receive geko™ treatment as an adjunct to standard care for wound management.

You may not qualify if:

• Pregnancy or breast feeding
• Use of any other neuro-modulation device.
• Use of a cardiac pacemaker
• Current use of TENS in the pelvic region, back or legs
• Contraindication to geko ™ NMES treatment
• No response to geko ™ NMES i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
• Participation in any other clinical trial that may interfere with the outcome of either trial.

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (2)

Central London Community Health Care NHS Trust

London, W10 6DZ, United Kingdom

Location

Norfolk Community Health and Care NHS Trust

Norwich, NR2 3TU, United Kingdom

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Agnes Collarte

  St Charles Centre for Health & Wellbeing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Therese Targett

CONTACT

07340903377; marie-therese.targett@firstkindmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: December 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)