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The gekoâ„¢ 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.
The gekoâ„¢ Cross Therapy REGISTRY - Wound represents a long-term project to integrate prospectively and systematically collected clinical data on all gekoâ„¢ 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 gekoâ„¢ 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 gekoâ„¢ Cross Therapy REGISTRY - Wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Patients who are receiving the geko device as part of standard of care for wound management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geko device | Device | Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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., gekoâ„¢ therapy vs standard care without gekoâ„¢ 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., gekoâ„¢ therapy vs standard care without gekoâ„¢ 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., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy | Up to 12 months from study entry |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will have been identified to receive gekoâ„¢ 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.
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Collarte | Central London Community Health Care NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health System | New York | New York | 11042 | United States | ||
| Central London Community Health Care NHS Trust |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014647 | Varicose Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| London |
| W10 6DZ |
| United Kingdom |
| Norfolk Community Health and Care NHS Trust | Norwich | NR2 3TU | United Kingdom |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |