Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

August 13, 2021 updated by: The Whiteley Clinic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SO2
Time Frame: 50 minutes
Transcutaneous oxygen saturation
50 minutes
OxyHb
Time Frame: 50 minutes
Oxyhaemoglobin
50 minutes
DeoxyHb
Time Frame: 50 minutes
Deoxyhaemoglobin
50 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Whiteley Clinic

Collaborators

VeinSense

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TWC-AC-2021-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants that are enrolled in the study will be assigned a unique Trial ID which will be used to anonymise data related to themselves.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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