NCT05011110

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Whiteley Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-08-18
• Last updated: 2021-08-18

Locations

1 site across 1 country: United Kingdom