Geko™ Cross Therapy Registry - Wound (CTR-Wound)

Geko™ Cross Therapy Registry - Wound An Observational Study for the Post Market Clinical Follow-up of Safety and Patient Outcomes for Patients Undergoing Peroneal Nerve Stimulation by Geko™

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Wound; Arterial Leg Ulcer
• Intervention / Treatment: Device: geko device

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W10 6DZ
    • Central London Community Health Care NHS Trust
  • Norwich, United Kingdom, NR2 3TU
    • Norfolk Community Health and Care NHS Trust
• United States
  • New York
    • New York, New York, United States, 11042
      • Northwell Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants will have been identified to receive geko™ therapy as part of their standard care for wound management. All participants must be at least 18 years of age and must be able to provide written informed consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of care; Patients who are receiving the geko device as part of standard of care for wound management	Device: geko device; Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	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	Up to 12 months from study entry
Frequency of serious adverse events	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	Up to 12 months from study entry
Frequency of device deficiencies	Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy	Up to 12 months from study entry

Collaborators and Investigators

• Sponsor: Firstkind Ltd
• Investigators: Principal Investigator: Agnes Collarte, Central London Community Health Care NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: medical device; registry; geko; wound therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: FSK-REG-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes