Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05009940
Status:
UNKNOWN
Last Update Posted:
2021-08-18
First Post:
2021-08-13
Brief Title:
Skin Oxygenation Whilst Wearing Gradusox Compression Hosiery
Sponsor:
The Whiteley Clinic
Organization:
The Whiteley Clinic
Study Overview
Official Title:
A Clinical Investigation Evaluating the Efficacy of Gradusox Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None