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Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).
To compare two daily geko™ device treatment durations, six hours and 12 hours, in conjunction with SC, with each other and to SC alone, in patients with venous leg ulcers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care alone (control) | No Intervention | Multilayer/multi component compression bandaging treatment | |
| 6 hours geko™ (no longer recruiting) | Active Comparator | geko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. |
|
| 12 hours geko™ | Active Comparator | geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geko™ medical device | Device | The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Linear healing rate (LHR) | Linear healing rate will be studied on a weekly basis | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate | Measured with the images taken | Upto 8 weeks |
| Pain reduction | Participant reported outcome of pain reduction using Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.
Note: At the randomisation visit, the study ulcer needs to be ≥ 2 cm2 and ≤ 30 cm2.
Exclusion Criteria:
Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomisation:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Harding, FRCGP FRCP FRCS | Welsh Wound Innovation Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trafalgar Group Medical Practice | Southsea | Portsmouth | PO5 3ND | United Kingdom | ||
| Crouch Oak Family Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36785909 | Result | Bull RH, Clements D, Collarte AJ, Harding KG. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J. 2023 Aug;20(6):2260-2268. doi: 10.1111/iwj.14107. Epub 2023 Feb 13. | |
| 37526355 | Result | Bull RH, Clements D, Collarte AJ, Harding KG. A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions. Adv Wound Care (New Rochelle). 2023 Dec;12(12):671-679. doi: 10.1089/wound.2023.0058. Epub 2023 Sep 5. |
| Label | URL |
|---|---|
| Device official website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 |
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The assessors will be blinded to the study participants and what treatment they are receiving.
| Upto 8 weeks |
| Change in Quality of Life | Change in Quality of Life based on participant reported outcomes using EQ-5D-5L questionnaire | Upto 8 weeks |
| Addlestone |
| KT15 2BH |
| United Kingdom |
| Barnsley Hospital NHS foundation Trust | Barnsley | S75 2EP | United Kingdom |
| Heart of Bath Medical Partnership | Bath | BA2 3HT | United Kingdom |
| West Walk Surgery | Bristol | BS37 4AX | United Kingdom |
| Rowden Surgery | Chippenham | SN15 2NB | United Kingdom |
| Lakeside Healthcare | Corby | NN17 2UR | United Kingdom |
| Royal Devon & Exeter NHS Foundation Trust | Exeter | EX2 5DW | United Kingdom |
| South Tyneside NHS Foundation Trust | Hebburn | NE31 1AT | United Kingdom |
| The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust | Kings Lynn | PE30 4ET | United Kingdom |
| Lancashire Care NHS Trust | Leyland | PR25 2TN | United Kingdom |
| Accelerate CIC | London | E1 4DG | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| Central London Community Healthcare | London | W10 6DZ | United Kingdom |
| Norfolk Community Health and Care NHS Trust | Norwich | NR2 3TU | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| The Adam Practice | Poole | BH16 5PW | United Kingdom |
| Hertfordshire Community NHS Trust | Stevenage | SG1 2UA | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| Breckland Alliance | Thetford | IP24 2HY | United Kingdom |
| Welsh wound Innovation Centre | Wales | CF72 8UX | United Kingdom |
| Worcestershire Royal Hospital | Worcester | WR5 1HN | United Kingdom |
| York Teaching Hospital NHS Foundation Trust | York | YO31 8HE | United Kingdom |
| Jan 18, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D007871 | Leg Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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