Clinical trial NCT05011110: Evaluating the Ease of Application, Removal, and Comfort of Gradusox™
Official title: Prospective Assessment to Evaluate the Ease of Application and Removal of GraduSOX™ VLU Kit Compared to Sigvaris™ Ulcer X VLU Kit, and Comfort in Use by Healthy Patients Who Have Completed Venous Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ease of Applying and Removing, and Comfort, of Compression Stockings
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
Collaborators: name: VeinSense
First posted: 2021-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over.
* Have known previous venous insufficiency that has been treated.
* Have no known current contraindication to the wearing of graduated compression hosiery.
* Have an ankle brachial pressure index (ABPI) between 0.8-1.2.
* Have no active ulceration.
* Are physically able to apply and remove hosiery kits safely.
* Have had successful surgery at The Whiteley Clinic and have had at least one follow-up to show no residual venous disease.

Exclusion Criteria:

* Under the age of 18.
* Have known arterial insufficiency (an ABPI of below 0.8).
* Have active ulceration.
* Be physically unable to put stocking on their own legs.
* Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, significant ankle oedema.
* Unable to give informed consent.
* Pregnant.
* Fragile skin that may be damaged whilst trying to apply or remove compression stockings.
* Previous DVT or complicated varicose veins that were not able to be completely treated and left residual venous reflux disease.

Primary outcomes:
measure: Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
timeFrame: Day 1 of 8
measure: Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
timeFrame: Day 1 of 8
measure: Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
timeFrame: Day 1 of 8
measure: Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
timeFrame: Day 1 of 8
measure: Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
timeFrame: Day 1 of 8
measure: Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
timeFrame: Day 1 of 8
measure: Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
timeFrame: Day 2 of 8
measure: Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
timeFrame: Day 2 of 8
measure: Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
timeFrame: Day 2 of 8
measure: Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
timeFrame: Day 2 of 8
measure: Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
timeFrame: Day 2 of 8
measure: Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
timeFrame: Day 2 of 8
measure: Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
timeFrame: Day 4 of 8
measure: Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
timeFrame: Day 4 of 8
measure: Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
timeFrame: Day 4 of 8
measure: Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
timeFrame: Day 4 of 8
measure: Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
timeFrame: Day 4 of 8
measure: Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
timeFrame: Day 4 of 8
measure: Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
timeFrame: Day 8 of 8
measure: Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
timeFrame: Day 8 of 8
measure: Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
timeFrame: Day 8 of 8
measure: Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
timeFrame: Day 8 of 8
measure: Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
timeFrame: Day 8 of 8
measure: Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
timeFrame: Day 8 of 8
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
Study officials:
affiliation: The Whiteley Clinic
name: Mark S Whiteley, MS FRCS(Gen) MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.