Clinical trial NCT05009940: Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery
Official title: A Clinical Investigation Evaluating the Efficacy of Gradusox™ Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
Collaborators: name: VeinSense
First posted: 2021-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SO2
timeFrame: 50 minutes
measure: OxyHb
timeFrame: 50 minutes
measure: DeoxyHb
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
Study officials:
affiliation: The Whiteley Clinic
name: Mark S Whiteley, MS FRCS(Gen) MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid. 2016 Jan 15;2016:1902.
citation: 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.
citation: 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.