Geko™ Cross Therapy Registry - Wound (CTR-Wound)
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- STATUS
- Recruiting
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- End date
- Mar 19, 2028
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- participants needed
- 2500
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- sponsor
- Firstkind Ltd
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).
Details
| Condition | Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer |
|---|---|
| Treatment | geko device |
| Clinical Study Identifier | NCT05007301 |
| Sponsor | Firstkind Ltd |
| Last Modified on | 4 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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