Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression HosieryNCT05009940
Skin Oxygenation Whilst Wearing Gradusox™ Compression Hosiery
A study testing Graduated compression stockings in people with Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery
- What is being tested?
- Graduated compression stockings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, GU2 7RF
Mark S Whiteley, 0330 0581 850, mark@thewhiteleyclinic.co.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- Graduated compression stockings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graduated compression stockingsDevice
Also called GraduSOX, Sigvaris
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Graduated compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
SO2
Transcutaneous oxygen saturation
Measured: 50 minutes
OxyHb
Oxyhaemoglobin
Measured: 50 minutes
DeoxyHb
Deoxyhaemoglobin
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression HosieryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- VeinSense
- Responsible party
- Sponsor
- Investigators
- Mark S Whiteley, MS FRCS(Gen) MBBS, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009940
- Sponsor's protocol ID
- TWC-AC-2021-02
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants that are enrolled in the study will be assigned a unique Trial ID which will be used to anonymise data related to themselves.
Publications
Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid. 2016 Jan 15;2016:1902.
PubMed 26771825Phillips 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.
PubMed 32383324Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010 Feb 9;3(1):8-18. doi: 10.6030/1939-067x-3.1.8.
PubMed 21423788
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Evaluating the Efficacy of Gradusox™ Compression Hosiery at Enhancing Dermal Oxygen Levels in Healthy Participants Post-varicose Vein Surgery.
- ClinicalTrials.gov ID
- NCT05009940
- Acronym / sponsor ID
- TWC-AC-2021-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Collaborators
- VeinSense
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradusox then Sigvaris compression stockings | Experimental | Device: Graduated compression stockingsThis 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. |
| Sigvaris then Gradusox compression stockings | Experimental | Device: Graduated compression stockingsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graduated compression stockingsAlso: GraduSOX, SigvarisBoth 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. | Device | Gradusox then Sigvaris compression stockings, Sigvaris then Gradusox compression stockings |
Primary outcome
SO2
Time frame: 50 minutes
Transcutaneous oxygen saturation
OxyHb
Time frame: 50 minutes
Oxyhaemoglobin
DeoxyHb
Time frame: 50 minutes
Deoxyhaemoglobin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 26771825Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid. 2016 Jan 15;2016:1902.
- Background: PubMed 32383324Phillips 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.
- Background: PubMed 21423788Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010 Feb 9;3(1):8-18. doi: 10.6030/1939-067x-3.1.8.
- Individual participant dataSharing planned: No. Participants that are enrolled in the study will be assigned a unique Trial ID which will be used to anonymise data related to themselves.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Whiteley, MS FRCS(Gen) MBBS principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graduated compression stockings in people with Effect of Compression Hosiery on the Local Tissue Oxygenation and Compare This Effect Against That Achieved by Standard Compression Hosiery, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS (Gen) MBBS (0330 058 1850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SO2 (time frame: 50 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.