Arterial Leg Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer, Wound
Conditions
Keywords
geko, wound therapy, medical device, registry
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).
Interventions
DEVICEgeko device
Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.
Sponsors
Firstkind Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events | Up to 12 months from study entry | 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 |
| Frequency of serious adverse events | Up to 12 months from study entry | 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 |
| Frequency of device deficiencies | Up to 12 months from study entry | Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy |
Countries
United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORAgnes Collarte
Central London Community Health Care NHS Trust
Outcome results
None listed