Geko™ Cross Therapy Registry - Wound

NCT05007301 | Active Not Recruiting FDA Device

• 1 other identifier: FSK-REG-002
• Study Type: observational
• Target: 2,500
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Keywords

geko; wound therapy; medical device; registry

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Standard of care

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

Device: geko device

Interventions

geko device DEVICE

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

Standard of care

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Sites (3)

Northwell Health System

New York, New York, 11042, United States

Location

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

Wounds and Injuries; Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Agnes Collarte

  Central London Community Health Care NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 16, 2021
• Study Start: April 4, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (1)