Evaluating the Ease of Application, Removal, and Comfort of Gradusox™

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ease of Applying and Removing, and Comfort, of Compression Stockings
• Intervention / Treatment: Device: Graduated compression stockings

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark S Whiteley, MS FRCS (Gen) MBBS; Phone Number: 0330 058 1850; Email: mark@thewhiteleyclinic.co.uk

Study Locations

• United Kingdom
  • Guildford, United Kingdom, GU2 7RF
    • Recruiting
    • The Whiteley Clinic
    • Contact: Mark S Whiteley; Phone Number: 0330 0581 850; Email: mark@thewhiteleyclinic.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GraduSOX (left leg) & Sigvaris (right leg); Half of participants will wear a GraduSOX compression stocking on their left leg whilst wearing a Sigvaris compression stocking on their right leg.	Device: Graduated compression stockings; 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.; Other Names: GraduSOX; Sigvaris
Experimental: GraduSOX (right leg) & Sigvaris (left leg); Half of participants will wear a GraduSOX compression stocking on their right leg whilst wearing a Sigvaris compression stocking on their left leg.	Device: Graduated compression stockings; 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.; Other Names: GraduSOX; Sigvaris

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: The Whiteley Clinic
• Collaborators: VeinSense
• Investigators: Principal Investigator: Mark S Whiteley, MS FRCS(Gen) MBBS, The Whiteley Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Power (sample size) calculator

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TWC-AC-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No