Ease of Applying and Removing, and Comfort, of Compression StockingsNCT05011110
Evaluating the Ease of Application, Removal, and Comfort of Gradusox™
A study testing Graduated compression stockings in people with Ease of Applying and Removing, and Comfort, of Compression Stockings, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ease of Applying and Removing, and Comfort, of Compression Stockings
- What is being tested?
- Graduated compression stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, GU2 7RF
Mark S Whiteley, 0330 0581 850, mark@thewhiteleyclinic.co.uk
About this study
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
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.
Read the 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.
- Being tested
- Graduated compression stockings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated compression stockingsDevice
Also called GraduSOX, Sigvaris
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Graduated compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: Day 8 of 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ease of Applying and Removing, and Comfort, of Compression StockingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- VeinSense
- Responsible party
- Sponsor
- Investigators
- Mark S Whiteley, MS FRCS(Gen) MBBS, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011110
- Sponsor's protocol ID
- TWC-AC-2021-01
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 17608682Ashby 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.
PubMed 24315520Raju 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.
PubMed 17980798O'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.
PubMed 23152202
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05011110
- Acronym / sponsor ID
- TWC-AC-2021-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Collaborators
- VeinSense
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GraduSOX (left leg) & Sigvaris (right leg) | Experimental | Device: Graduated compression stockingsHalf of participants will wear a GraduSOX compression stocking on their left leg whilst wearing a Sigvaris compression stocking on their right leg. |
| GraduSOX (right leg) & Sigvaris (left leg) | Experimental | Device: Graduated compression stockingsHalf of participants will wear a GraduSOX compression stocking on their right leg whilst wearing a Sigvaris compression stocking on their left leg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated compression stockingsAlso: GraduSOX, SigvarisBoth 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. | Device | GraduSOX (left leg) & Sigvaris (right leg), GraduSOX (right leg) & Sigvaris (left leg) |
Primary outcome
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
Time frame: Day 1 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
Time frame: Day 1 of 8
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'.
Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
Time frame: Day 1 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
Time frame: Day 1 of 8
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'.
Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
Time frame: Day 1 of 8
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'.
Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
Time frame: Day 1 of 8
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'.
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
Time frame: Day 2 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
Time frame: Day 2 of 8
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'.
Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
Time frame: Day 2 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
Time frame: Day 2 of 8
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'.
Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
Time frame: Day 2 of 8
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'.
Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
Time frame: Day 2 of 8
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'.
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
Time frame: Day 4 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
Time frame: Day 4 of 8
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'.
Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
Time frame: Day 4 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
Time frame: Day 4 of 8
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'.
Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
Time frame: Day 4 of 8
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'.
Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
Time frame: Day 4 of 8
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'.
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris.
Time frame: Day 8 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to apply compared to Gradusox.
Time frame: Day 8 of 8
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'.
Number of participants that graded Gradusox stockings as easier to remove compared to Sigvaris.
Time frame: Day 8 of 8
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'.
Number of participants that graded Sigvaris stockings as easier to remove compared to Gradusox.
Time frame: Day 8 of 8
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'.
Number of participants that graded Gradusox stockings as more comfortable compared to Sigvaris.
Time frame: Day 8 of 8
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'.
Number of participants that graded Sigvaris stockings as more comfortable compared to Gradusox.
Time frame: Day 8 of 8
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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 17608682Briggs 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.
- Background: PubMed 24315520Ashby 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.
- Background: PubMed 17980798Raju 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.
- Background: PubMed 23152202O'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.
- Power (sample size) calculatorLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Whiteley, MS FRCS(Gen) MBBS principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated compression stockings in people with Ease of Applying and Removing, and Comfort, of Compression Stockings, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS (Gen) MBBS (0330 058 1850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that graded Gradusox stockings as easier to apply compared to Sigvaris. (time frame: Day 1 of 8). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011110, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.