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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Graduated compression stockings


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GraduSOX (left leg) & Sigvaris (right leg)<br>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<br>* 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.<br>* Other names: Sigvaris;|
| Experimental: GraduSOX (right leg) & Sigvaris (left leg)<br>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<br>* 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.<br>* Other names: Sigvaris;|

What is the study measuring?
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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 |