NCT05011110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 11, 2021

Last Update Submit

August 17, 2021

Conditions

Ease of Applying and Removing, and Comfort, of Compression Stockings

Outcome Measures

Primary Outcomes (24)

  • 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

Study Arms (2)

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.

Device: Graduated compression stockings

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.

Device: Graduated compression stockings

Interventions

Graduated compression stockingsDEVICE

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.

Also known as: GraduSOX, Sigvaris
GraduSOX (left leg) & Sigvaris (right leg)GraduSOX (right leg) & Sigvaris (left leg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17608682BACKGROUND

  • 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.

    PMID: 24315520BACKGROUND

  • 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.

    PMID: 17980798BACKGROUND

  • 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.

    PMID: 23152202BACKGROUND

Related Links

Study Officials

  • Mark S Whiteley, MS FRCS(Gen) MBBS

    The Whiteley Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Whiteley, MS FRCS (Gen) MBBS

CONTACT

0330 058 1850mark@thewhiteleyclinic.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)