Geko™ Cross Therapy Registry - Wound

Active, not recruiting

• Conditions: Wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Arterial Leg Ulcer
• Interventions: Device: geko device

• Registration Number: NCT05007301
• Lead Sponsor: Firstkind Ltd

Brief Summary

The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.

Detailed Description

The geko™ Cross Therapy REGISTRY - Wound represents a long-term project to integrate prospectively and systematically collected clinical data on all geko™ W wound devices (or W device variants) used in SC pathways for wound management allowing for the monitoring of patient outcomes during a follow-up period of up to four follow-up visits.

The clinical database collected for the geko™ CTR - Wound will form part of the overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. There will be up to 50 contributing centres globally. Participants are asked at the time of signing up for the geko™ Cross Therapy REGISTRY - Wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-16
• Study Start: 2022-04-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2027-09
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Aged ≥ 18 years
2. Intact healthy skin at the site of geko™ device application.
3. Willing and able to give written informed consent
4. Presence of an ulcerative wound to the lower leg
5. Identified to receive geko™ therapy as part of their standard care for wound management.

Exclusion Criteria

1. Pregnancy or breast feeding.
2. Use of any other neuro-modulation device.
3. Current use of TENS in the pelvic region, back or legs
4. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
5. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	geko device	Patients who are receiving the geko device as part of standard of care for wound management

Primary Outcome Measures

Name	Time	Method
Frequency of serious adverse events	Up to 12 months from study entry	Obtain frequency of serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Frequency of device deficiencies	Up to 12 months from study entry	Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Frequency of adverse events	Up to 12 months from study entry	Obtain frequency of adverse events (AEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy

Trial Locations

Locations (3)

Norfolk Community Health and Care NHS Trust; 🇬🇧 Norwich, United Kingdom

Northwell Health System; 🇺🇸 New York, New York, United States

Central London Community Health Care NHS Trust; 🇬🇧 London, United Kingdom