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| Name | Class |
|---|---|
| VeinSense | UNKNOWN |
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The primary objective is to evaluate the effect of Gradusoxâ„¢ compression hosiery on the local tissue oxygenation and compare this effect against that achieved by standard compression hosiery.
After being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) first, GraduSOX on their right leg and Sigvaris on their left leg, then GraduSOX on their left leg and Sigvaris on their right leg, or b) first, GraduSOX on their left leg and Sigvaris on their right leg, then GraduSOX on their right leg and Sigvaris on their left leg.
Participants will attend the clinic and be fitted with their stockings. Non-invasive probes will be taped to the skin above the inner ankle on both legs - these take measurements for SO2, oxyHb and deoxyHb every second. Measurements for these variables will be taken for 15 minutes whilst participants are not wearing stockings, as well as with stockings (worn in the order assigned to them). During these 15 minutes, participants will lie in supine for 5 minutes, then in sitting position for 5 minutes, then will return to supine for the last 5 minutes.
Between each stocking, participants will be asked to take a 10 minute walk and return to the recliner in supine to re-equilibrate for a further 15 minutes.
The total time that measurements are taken for per participant is 50 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gradusox then Sigvaris compression stockings | Experimental | This arm refers to the order of interventions received by the participant. The first intervention received by participants in this arm are Gradusox compression stockings applied to both legs. After a washout period, the second intervention received are Sigvaris compression stockings applied to both legs. |
|
| Sigvaris then Gradusox compression stockings | Experimental | This arm refers to the order of interventions received by the participant. The first intervention received by participants in this arm are Sigvaris compression stockings applied to both legs. After a washout period, the second intervention received are Gradusox compression stockings applied to both legs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graduated compression stockings | Device | Both GraduSOX and Sigvaris are graduated compression stockings. These exert the greatest degree of of compression at the ankle, and the level of compression gradually decreases up the garment. |
| Measure | Description | Time Frame |
|---|---|---|
| SO2 | Transcutaneous oxygen saturation | 50 minutes |
| OxyHb | Oxyhaemoglobin | 50 minutes |
| DeoxyHb | Deoxyhaemoglobin | 50 minutes |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark S Whiteley, MS FRCS (Gen) MBBS | Contact | 0330 058 1850 | mark@thewhiteleyclinic.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mark S Whiteley, MS FRCS(Gen) MBBS | The Whiteley Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Whiteley Clinic | Recruiting | Guildford | GU2 7RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26771825 | Background | Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid. 2016 Jan 15;2016:1902. | |
| 32383324 | Background | Phillips CJ, Humphreys I, Thayer D, Elmessary M, Collins H, Roberts C, Naik G, Harding K. Cost of managing patients with venous leg ulcers. Int Wound J. 2020 Aug;17(4):1074-1082. doi: 10.1111/iwj.13366. Epub 2020 May 7. |
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Participants that are enrolled in the study will be assigned a unique Trial ID which will be used to anonymise data related to themselves.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2023 | |
| Reset | Mar 6, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2023 | Mar 6, 2024 |
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| 21423788 | Background | Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010 Feb 9;3(1):8-18. doi: 10.6030/1939-067x-3.1.8. |