Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

Not Applicable

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

• Registration Number: NCT05009940
• Lead Sponsor: The Whiteley Clinic

Brief 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.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-13
• Last Update Submitted: 2021-08-13
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
OxyHb	50 minutes	Oxyhaemoglobin
SO2	50 minutes	Transcutaneous oxygen saturation
DeoxyHb	50 minutes	Deoxyhaemoglobin

Trial Locations

Locations (1)

The Whiteley Clinic; 🇬🇧 Guildford, United Kingdom