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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05007301
Other study ID # FSK-REG-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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