Geko™ Cross Therapy Registry - Wound

NCT ID: NCT05007301

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2028-03-31

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).

Conditions

Wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Arterial Leg Ulcer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of care

Patients who are receiving the geko device as part of standard of care for wound management

geko device

Intervention Type: DEVICE

Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

Interventions

geko device

Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firstkind Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes Collarte

Role: PRINCIPAL_INVESTIGATOR

Central London Community Health Care NHS Trust

Locations

Northwell Health System

New York, New York, United States

Central London Community Health Care NHS Trust

London, , United Kingdom

Norfolk Community Health and Care NHS Trust

Norwich, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

FSK-REG-002

Identifier Type: -

Identifier Source: org_study_id