Status:
UNKNOWN
Geko™ KM40C Hydrogel Skin Adhesion Trial (XW-3)
Lead Sponsor:
Firstkind Ltd
Conditions:
Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06084546
Start Date
December 1 2023
End Date
December 1 2024
Last Update
October 16 2023
Active Locations (2)
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1
Central London Community Health Care NHS Trust
London, United Kingdom, W10 6DZ
2
Norfolk Community Health and Care NHS Trust
Norwich, United Kingdom, NR2 3TU