Geko™ Cross Therapy Registry - Wound

Diabetic Foot Ulcer Clinical Trial

— CTR-Wound  

Official title:

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™

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007301
• Other study ID #: FSK-REG-002
• Status: Active, not recruiting
• Start date: April 4, 2022
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: March 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Leg Ulcer
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wound
• Wounds and Injuries

Intervention

Device:
• geko device
Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

Locations

Country	Name	City	State
United Kingdom	Central London Community Health Care NHS Trust	London
United Kingdom	Norfolk Community Health and Care NHS Trust	Norwich
United States	Northwell Health System	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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