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

The Whiteley Clinic

Status: Unknown

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

Treatments: Device: Graduated compression stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT05011110

TWC-AC-2021-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

GraduSOX (left leg) & Sigvaris (right leg)

Experimental group

Description:

Half of participants will wear a GraduSOX compression stocking on their left leg whilst wearing a Sigvaris compression stocking on their right leg.

Treatment:

Device: Graduated compression stockings

GraduSOX (right leg) & Sigvaris (left leg)

Experimental group

Description:

Half of participants will wear a GraduSOX compression stocking on their right leg whilst wearing a Sigvaris compression stocking on their left leg.

Treatment:

Device: Graduated compression stockings