Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery

NCT05009940 | Unknown

• 1 other identifier: TWC-AC-2021-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• SO2

  Transcutaneous oxygen saturation

  50 minutes

• OxyHb

  Oxyhaemoglobin

  50 minutes

• DeoxyHb

  Deoxyhaemoglobin

  50 minutes

Study Arms (2)

Gradusox then Sigvaris compression stockings

EXPERIMENTAL

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

Sigvaris then Gradusox compression stockings

EXPERIMENTAL

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

Interventions

Graduated compression stockings DEVICE

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.

Also known as: GraduSOX, Sigvaris

Gradusox then Sigvaris compression stockings; Sigvaris then Gradusox compression stockings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Whiteley Clinic: lead
• VeinSense: collaborator

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

RECRUITING

Related Publications (3)

• Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid. 2016 Jan 15;2016:1902.

  PMID: 26771825 BACKGROUND

• Phillips CJ, Humphreys I, Thayer D, Elmessary M, Collins H, Roberts C, Naik G, Harding K. Cost of managing patients with venous leg ulcers. Int Wound J. 2020 Aug;17(4):1074-1082. doi: 10.1111/iwj.13366. Epub 2020 May 7.

  PMID: 32383324 BACKGROUND

• Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010 Feb 9;3(1):8-18. doi: 10.6030/1939-067x-3.1.8.

  PMID: 21423788 BACKGROUND

Study Officials

• Mark S Whiteley, MS FRCS(Gen) MBBS

  The Whiteley Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Whiteley, MS FRCS (Gen) MBBS

CONTACT

0330 058 1850; mark@thewhiteleyclinic.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)