NCT05009940

Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

A Clinical Investigation Evaluating the Efficacy of Gradusox™ Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The Whiteley Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate the effect of Gradusox™ compression hosiery on the local tissue oxygenation and compare this effect against that achieved by standard compression hosiery.

Detailed description

After being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) first, GraduSOX on their right leg and Sigvaris on their left leg, then GraduSOX on their left leg and Sigvaris on their right leg, or b) first, GraduSOX on their left leg and Sigvaris on their right leg, then GraduSOX on their right leg and Sigvaris on their left leg. Participants will attend the clinic and be fitted with their stockings. Non-invasive probes will be taped to the skin above the inner ankle on both legs - these take measurements for SO2, oxyHb and deoxyHb every second. Measurements for these variables will be taken for 15 minutes whilst participants are not wearing stockings, as well as with stockings (worn in the order assigned to them). During these 15 minutes, participants will lie in supine for 5 minutes, then in sitting position for 5 minutes, then will return to supine for the last 5 minutes. Between each stocking, participants will be asked to take a 10 minute walk and return to the recliner in supine to re-equilibrate for a further 15 minutes. The total time that measurements are taken for per participant is 50 minutes.

Conditions

• Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery

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