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Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

Sponsor
The Whiteley Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05009940
Collaborator
VeinSense (Other)
32
Enrollment
1
Location
2
Arms
4
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Graduated compression stockings
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Investigation Evaluating the Efficacy of Gradusox™ Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery.
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gradusox then Sigvaris 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.

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.
Other Names:
  • GraduSOX
  • Sigvaris

    		•
    Experimental: Sigvaris then Gradusox 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.

    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.
    Other Names:
  • GraduSOX
  • Sigvaris

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SO2 [50 minutes]

      Transcutaneous oxygen saturation

    2. OxyHb [50 minutes]

      Oxyhaemoglobin

    3. DeoxyHb [50 minutes]

      Deoxyhaemoglobin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • Adults aged 18 and over.

    • Have known previous venous insufficiency that has been treated.

    • Have no known current contraindication to the wearing of graduated compression hosiery.

    • Have an ankle brachial pressure index (ABPI) between 0.8-1.2.

    • Have no active ulceration.

    • Are physically able to apply and remove hosiery kits safely.

    • Have had successful surgery at The Whiteley Clinic and have had at least one follow-up to show no residual venous disease.

    Exclusion Criteria

    • Under the age of 18.

    • Have known arterial insufficiency (an ABPI of below 0.8).

    • Have active ulceration.

    • Be physically unable to put stocking on their own legs.

    • Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, significant ankle oedema.

    • Unable to give informed consent.

    • Pregnant.

    • Fragile skin that may be damaged whilst trying to apply or remove compression stockings.

    • Previous DVT or complicated varicose veins that were not able to be completely treated and left residual venous reflux disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Whiteley Clinic Guildford United Kingdom GU2 7RF

    Sponsors and Collaborators

    • The Whiteley Clinic
    • VeinSense

    Investigators

    • Principal Investigator: Mark S Whiteley, MS FRCS(Gen) MBBS, The Whiteley Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Whiteley Clinic
    ClinicalTrials.gov Identifier:
    NCT05009940
    Other Study ID Numbers:
    • TWC-AC-2021-02
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Aug 18, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 18, 2021