Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery
- Conditions
- Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery
- Interventions
- Device: Graduated compression stockings
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Gradusox then Sigvaris compression stockings Graduated compression stockings This arm refers to the order of interventions received by the participant. The first intervention received by participants in this arm are Gradusox compression stockings applied to both legs. After a washout period, the second intervention received are Sigvaris compression stockings applied to both legs. Sigvaris then Gradusox compression stockings Graduated compression stockings This arm refers to the order of interventions received by the participant. The first intervention received by participants in this arm are Sigvaris compression stockings applied to both legs. After a washout period, the second intervention received are Gradusox compression stockings applied to both legs.
- Primary Outcome Measures
Name Time Method OxyHb 50 minutes Oxyhaemoglobin
SO2 50 minutes Transcutaneous oxygen saturation
DeoxyHb 50 minutes Deoxyhaemoglobin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Whiteley Clinic
🇬🇧Guildford, United Kingdom