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| Name | Class |
|---|---|
| VeinSense | UNKNOWN |
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The aims of this study are to evaluate the comfort, and ease of application and removal, of GraduSOX™ compression stockings compared to standard compression stockings of the same compression class.
After being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) GraduSOX on their right leg and Sigvaris on their left leg, or b) Sigvaris on their right leg and GraduSOX on their left leg. At Day 1, participants will attend the clinic and be fitted with their stockings and given an Evaluation Form. The Evaluation Form has four sections to be completed on Day 1, Day 2, Day 4 and Day 8 of the study. Each section asks multiple choice questions related to the comfort and ease of applying and removing each stocking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GraduSOX (left leg) & Sigvaris (right leg) | Experimental | Half of participants will wear a GraduSOX compression stocking on their left leg whilst wearing a Sigvaris compression stocking on their right leg. |
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| GraduSOX (right leg) & Sigvaris (left leg) | Experimental | Half of participants will wear a GraduSOX compression stocking on their right leg whilst wearing a Sigvaris compression stocking on their left leg. |
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| 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 |
|---|---|---|
| Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 1 of 8 |
| Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 1 of 8 |
| Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 1 of 8 |
| Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 1 of 8 |
| Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 1 of 8 |
| Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox. |
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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 |
|---|---|---|---|
| 17608682 | Background | Briggs M, Flemming K. Living with leg ulceration: a synthesis of qualitative research. J Adv Nurs. 2007 Aug;59(4):319-28. doi: 10.1111/j.1365-2648.2007.04348.x. Epub 2007 Jul 2. | |
| 24315520 | Background | Ashby RL, Gabe R, Ali S, Adderley U, Bland JM, Cullum NA, Dumville JC, Iglesias CP, Kang'ombe AR, Soares MO, Stubbs NC, Torgerson DJ. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet. 2014 Mar 8;383(9920):871-9. doi: 10.1016/S0140-6736(13)62368-5. Epub 2013 Dec 6. |
| Label | URL |
|---|---|
| Power (sample size) calculator | View source |
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Participants that are enrolled in the study will be assigned a unique Trial ID which will be used to anonymise the data they provide on the Evaluation Form.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 30, 2023 | |
| Reset | Feb 22, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2023 | Feb 22, 2024 |
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Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. |
| Day 1 of 8 |
| Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 2 of 8 |
| Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 2 of 8 |
| Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 2 of 8 |
| Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 2 of 8 |
| Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 2 of 8 |
| Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 2 of 8 |
| Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 4 of 8 |
| Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 4 of 8 |
| Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 4 of 8 |
| Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 4 of 8 |
| Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 4 of 8 |
| Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 4 of 8 |
| Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 8 of 8 |
| Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 8 of 8 |
| Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 8 of 8 |
| Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very easy', 2 is 'fairly easy', 3 is 'neither easy nor difficult', 4 is 'quite difficult', and 5 is 'very difficult'. | Day 8 of 8 |
| Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 8 of 8 |
| Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox. | Participants use a 5-point discrete linear analogue scale 1-5, where 1 is 'very comfortable', 2 is 'comfortable', 3 is 'neither comfortable nor uncomfortable', 4 is 'uncomfortable', and 5 is 'very uncomfortable'. | Day 8 of 8 |
| 17980798 | Background | Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007 Nov;21(6):790-5. doi: 10.1016/j.avsg.2007.07.014. |
| 23152202 | Background | O'Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000265. doi: 10.1002/14651858.CD000265.pub3. |