Compression BandageNCT05178147
Feasibility Trial of GraduCheck® to Enable Nurses to Achieve Ideal Sub-Bandage Pressures
A study testing Compression bandaging without reference to GraduCheck pressure measurements and Compression bandaging using GraduCheck pressure measurements to monitor compression pressure in people with Compression Bandage, run by The Whiteley Clinic.
Trial summary
The purpose of this study is: to evaluate the feasibility of using the GraduCheck® device to optimise the compression profile attained by experienced tissue viability nurses (TVNs) using standard, commonly prescribed, multi-layer bandage systems (Actico, Coban and K2) on healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compression Bandage
- What is being tested?
- Compression bandaging without reference to GraduCheck pressure measurements and Compression bandaging using GraduCheck pressure measurements to monitor compression pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Feb 2022
- 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 an ankle brachial pressure index (ABPI) between 0.8-1.2 (at assessment)
- Have no active ulceration
Who cannot join
- Under the age of 18
- Unable to wear compression bandages of hosiery for any reason
- Unable to walk unaided and at normal speed for at least one mile
- Previous history of deep vein thrombosis
- Have known arterial insufficiency (an ABPI of below 0.8) (at assessment)
- Unable to tolerate a cuff at 40 mmHg around ankle (at assessment)
Show all 11Show fewer
- Have active ulceration
- Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, or significant ankle oedema
- Unable to give informed consent
- Pregnant
- Fragile skin that may be damaged whilst trying to apply compression bandaging
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Trial to Evaluate the Use of GraduCheck® in Enabling Experienced Tissue Viability Nurses to Achieve Ideal Sub-Bandage Pressures in Healthy Volunteers
The purpose of this study is:
- to evaluate the feasibility of using the GraduCheck® device to optimise the compression profile attained by experienced tissue viability nurses (TVNs) using standard, commonly prescribed, multi-layer bandage systems (Actico, Coban and K2) on healthy volunteers.
- to evaluate the feasibility of using the Graducheck® device to ensure that it does not add excessive time to apply the different sorts of compression bandaging (Actico, Coban and K2) when using the GraduCheck® system to monitor the compression.
Read the detailed description
This trial is designed to investigate the feasibility of using the GraduCheck® device to achieve optimal compression profiles under compression bandages by experienced TVNs and to check that this does not add excessive time to the bandaging.
This prospective feasibility trial compares the sub-bandage compression profiles achieved by experienced TVNs when applying compression to volunteers without any pressure feedback (hence using experience only), compared with applying compression whilst using the GraduCheck® numerical display for compression feedback during application.
This comparison will be made using three different compression systems on each volunteer. The last system used should be Urgo K2.
The three multi-layer compression bandaging systems will be:
- Actico
- Coban
- Urgo K2
Place of study The study is to be carried out at the Woundcare Consultants Clinic (with a Covid-secure protocol in place).
Healthy Volunteers Twelve (12) healthy volunteers will be recruited.
Assessment of volunteers Before the study commences, any potential volunteer who expresses an interest in joining the study will be given a patient information sheet and a consent form.
Those that have read the patient information sheet and consent form, and still wish to be involved, will be invited in for assessment.
Healthy volunteer participants who fulfil the above criteria (part from those measured at the assessment) will be assessed to by using a Doppler Ability ultrasound device to measure the Ankle Brachial Pressure Index (ABPI), exclude any lower limb ischaemic disease. Healthy volunteer participants must have an ABPI reading between 0.8 and 1.2.
A sphygmomanometer cuff will be placed around the lower legs at the ankle, one after the other, and inflated to 40mmHg. Volunteers will need to be able to tolerate this to be included.
Consent Healthy volunteers who fulfil the inclusion and exclusion criteria (including the assessment of ABPI and cuff inflated around the ankle), to a maximum of 12, will be invited to consent for the study.
The healthy volunteers will have been given an opportunity to discuss any points of the study or consent before signing the consent form.
As part of the consenting process, the healthy volunteers will be informed that they can withdraw at any stage, for any reason, without having to tell the organisers of their reason.
The study protocol The volunteer will be allocated to the TVN who will perform six sequential compression bandage procedures on one of the volunteer's legs, the first three blinded to the GraduCheck® readings and the second three using the GraduCheck®readings to inform the compression being applied. The GraduCheck® compression sensor device will be applied in each of the six sessions.
The time of each compression application will be measured. There will be 12 volunteers treated and 3 TVNs - so each TVN will treat 4 of the volunteers.
The leg to be selected will be on sealed envelope selection (12 sealed envelopes - 6 left and 6 right).
The process will be as follows:
- - application of first compression system (Actico), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Actico compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Actico compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party without any communication of the result to the TVN (to prevent any bias before the second two blinded compression system applications)
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of second compression system (Coban), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Coban compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Coban compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party without any communication of the result to the TVN (to prevent any bias before the next blinded compression system application)
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of third compression system (Urgo K2), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Urgo K2 compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Urgo K2 compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of first compression system (Actico), using GraduCheck®to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Actico compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Actico compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of second compression system (Coban), using GraduCheck® to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Coban compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Coban compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of third compression system (Urgo K2), using GraduCheck® to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Urgo K2 compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Urgo K2 compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- if the healthy volunteer is part of the comfort study, then this compression will stay in place and will not be removed
- if the healthy volunteer is not part of the comfort study, then once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before being allowed to leave and go home.
- Conditions
- Compression Bandage
- Being tested
- Compression bandaging without reference to GraduCheck pressure measurements, Compression bandaging using GraduCheck pressure measurements to monitor compression pressure
- Keywords
- compression, bandages, wraps, pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandaging without reference to GraduCheck pressure measurementsDevice
To apply compression bandages to legs of volunteers without guidance from the Graducheck device (that lies below the bandages) to assess use of the device.
Compression bandaging using GraduCheck pressure measurements to monitor compression pressureDevice
To apply compression bandages to legs of volunteers using the guidance from the Graducheck device (that lies below the bandages) to assess use of the device.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | Volunteers having compression bandages applied to their legs. Receives: Device: Compression bandaging without reference to GraduCheck pressure measurements; Device: Compression bandaging using GraduCheck pressure measurements to monitor compression pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure profile
Pressure profile obtained under compression bandaging with and without GraduCheck guidance
Measured: 1 day
Secondary outcomes (1)
Time taken to bandage with GraduCheck guidance
Assessment to see how much extra time is used to apply compression with GraduCheck feedback during compression
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Compression BandageStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To assess the feasibility of using the new GraduCheck® device to enable experienced Tissue Viability Nurses to bandage legs with an optimal pressure profile beneath the bandage, without causing excessive time to be spent.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Whiteley, The Whiteley Clinic
- Investigators
- Mark S Whiteley, MS, Principal investigator, The Whiteley Clinic Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178147
- Sponsor's protocol ID
- VS-SH-2021-01
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results from the study will be presented and submitted of publication in peer-reviewed journals. The results will be presented in table and graphic format. The results from individual volunteers will be included but no personal or identifiable data.
Publications
Bobbink P, Larkin PJ, Probst S. Experiences of Venous Leg Ulcer persons following an individualised nurse-led education: protocol for a qualitative study using a constructivist grounded theory approach. BMJ Open. 2020 Nov 26;10(11):e042605. doi: 10.1136/bmjopen-2020-042605.
PubMed 33243816Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK's National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020 Dec 22;10(12):e045253. doi: 10.1136/bmjopen-2020-045253.
PubMed 33371051
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial to Evaluate the Use of GraduCheck® in Enabling Experienced Tissue Viability Nurses to Achieve Ideal Sub-Bandage Pressures in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05178147
- Acronym / sponsor ID
- VS-SH-2021-01
- Conditions
- Compression Bandage
- Keywords
- compression, bandages, wraps, pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 5 Jan 2022 (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 purpose of this study is:
- to evaluate the feasibility of using the GraduCheck® device to optimise the compression profile attained by experienced tissue viability nurses (TVNs) using standard, commonly prescribed, multi-layer bandage systems (Actico, Coban and K2) on healthy volunteers.
- to evaluate the feasibility of using the Graducheck® device to ensure that it does not add excessive time to apply the different sorts of compression bandaging (Actico, Coban and K2) when using the GraduCheck® system to monitor the compression.
Detailed description
This trial is designed to investigate the feasibility of using the GraduCheck® device to achieve optimal compression profiles under compression bandages by experienced TVNs and to check that this does not add excessive time to the bandaging.
This prospective feasibility trial compares the sub-bandage compression profiles achieved by experienced TVNs when applying compression to volunteers without any pressure feedback (hence using experience only), compared with applying compression whilst using the GraduCheck® numerical display for compression feedback during application.
This comparison will be made using three different compression systems on each volunteer. The last system used should be Urgo K2.
The three multi-layer compression bandaging systems will be:
- Actico
- Coban
- Urgo K2
Place of study The study is to be carried out at the Woundcare Consultants Clinic (with a Covid-secure protocol in place).
Healthy Volunteers Twelve (12) healthy volunteers will be recruited.
Assessment of volunteers Before the study commences, any potential volunteer who expresses an interest in joining the study will be given a patient information sheet and a consent form.
Those that have read the patient information sheet and consent form, and still wish to be involved, will be invited in for assessment.
Healthy volunteer participants who fulfil the above criteria (part from those measured at the assessment) will be assessed to by using a Doppler Ability ultrasound device to measure the Ankle Brachial Pressure Index (ABPI), exclude any lower limb ischaemic disease. Healthy volunteer participants must have an ABPI reading between 0.8 and 1.2.
A sphygmomanometer cuff will be placed around the lower legs at the ankle, one after the other, and inflated to 40mmHg. Volunteers will need to be able to tolerate this to be included.
Consent Healthy volunteers who fulfil the inclusion and exclusion criteria (including the assessment of ABPI and cuff inflated around the ankle), to a maximum of 12, will be invited to consent for the study.
The healthy volunteers will have been given an opportunity to discuss any points of the study or consent before signing the consent form.
As part of the consenting process, the healthy volunteers will be informed that they can withdraw at any stage, for any reason, without having to tell the organisers of their reason.
The study protocol The volunteer will be allocated to the TVN who will perform six sequential compression bandage procedures on one of the volunteer's legs, the first three blinded to the GraduCheck® readings and the second three using the GraduCheck®readings to inform the compression being applied. The GraduCheck® compression sensor device will be applied in each of the six sessions.
The time of each compression application will be measured. There will be 12 volunteers treated and 3 TVNs - so each TVN will treat 4 of the volunteers.
The leg to be selected will be on sealed envelope selection (12 sealed envelopes - 6 left and 6 right).
The process will be as follows:
- - application of first compression system (Actico), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Actico compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Actico compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party without any communication of the result to the TVN (to prevent any bias before the second two blinded compression system applications)
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of second compression system (Coban), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Coban compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Coban compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party without any communication of the result to the TVN (to prevent any bias before the next blinded compression system application)
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of third compression system (Urgo K2), blinded to GraduCheck® results:
- the volunteer is sat in the treatment chair and TVN prepares the Urgo K2 compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, but positioned so the TVN is unable to see the output
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Urgo K2 compression system as per manufacturer's instructions
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded by a third party
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of first compression system (Actico), using GraduCheck®to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Actico compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Actico compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of second compression system (Coban), using GraduCheck® to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Coban compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Coban compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before commencement of the next application
- - application of third compression system (Urgo K2), using GraduCheck® to inform compression application:
- the volunteer is sat in the treatment chair and TVN prepares the Urgo K2 compression system and the GraduCheck® compression sensor
- the GraduCheck® compression system is turned on to record the compression, and the output screen turned to the TVN so they can monitor the compression being applied in real time
- when ready, the timer is started
- the GraduCheck® sensor strip will be applied antero-laterally on the selected limb after the first non-compression (padding) layer is applied. It is important that in volunteers with a significant space from the lateral malleolus to their calf (Achilles tendon) have additional padding placed (at the TVNs discretion).
- the TVN then applies the Urgo K2 compression system as per manufacturer's instructions, using the output from the GraduCheck® to keep as close as possible to the prescribed pressure of 40 mmHg at the ankle reducing to 20 mmHg just below the knee
- when the TVN has completed the job the timer is stopped and the time of application is noted
- the compression profile measured by the GraduCheck® system is recorded
- if the healthy volunteer is part of the comfort study, then this compression will stay in place and will not be removed
- if the healthy volunteer is not part of the comfort study, then once the figures have been recorded from the GraduCheck® device and the time of the compression application has been noted, the compression system will be removed
- the healthy volunteer will be asked to stand, stretch and go for a short walk before being allowed to leave and go home.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess the feasibility of using the new GraduCheck® device to enable experienced Tissue Viability Nurses to bandage legs with an optimal pressure profile beneath the bandage, without causing excessive time to be spent.
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Experimental | Device: Compression bandaging without reference to GraduCheck pressure measurements, Device: Compression bandaging using GraduCheck pressure measurements to monitor compression pressureVolunteers having compression bandages applied to their legs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 and over
- Have an ankle brachial pressure index (ABPI) between 0.8-1.2 (at assessment)
- Have no active ulceration
Key exclusion criteria (11 listed)
- Under the age of 18
- Unable to wear compression bandages of hosiery for any reason
- Unable to walk unaided and at normal speed for at least one mile
- Previous history of deep vein thrombosis
- Have known arterial insufficiency (an ABPI of below 0.8) (at assessment)
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 |
|---|---|---|
| Compression bandaging without reference to GraduCheck pressure measurementsTo apply compression bandages to legs of volunteers without guidance from the Graducheck device (that lies below the bandages) to assess use of the device. | Device | Volunteers |
| Compression bandaging using GraduCheck pressure measurements to monitor compression pressureTo apply compression bandages to legs of volunteers using the guidance from the Graducheck device (that lies below the bandages) to assess use of the device. | Device | Volunteers |
Primary outcome
Pressure profile
Time frame: 1 day
Pressure profile obtained under compression bandaging with and without GraduCheck guidance
1 secondary outcome
Time taken to bandage with GraduCheck guidance
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Background: PubMed 33243816Bobbink P, Larkin PJ, Probst S. Experiences of Venous Leg Ulcer persons following an individualised nurse-led education: protocol for a qualitative study using a constructivist grounded theory approach. BMJ Open. 2020 Nov 26;10(11):e042605. doi: 10.1136/bmjopen-2020-042605.
- Background: PubMed 33371051Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK's National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020 Dec 22;10(12):e045253. doi: 10.1136/bmjopen-2020-045253.
- Management of chronic venous leg ulcers; A National Clinical GuidelineLink provided by the sponsor.
- Individual participant dataSharing planned: No. The results from the study will be presented and submitted of publication in peer-reviewed journals. The results will be presented in table and graphic format. The results from individual volunteers will be included but no personal or identifiable data.
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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 principal investigator
The Whiteley Clinic Ltd
Questions about this trial
What is this clinical trial studying?
A study testing Compression bandaging without reference to GraduCheck pressure measurements and Compression bandaging using GraduCheck pressure measurements to monitor compression pressure in people with Compression Bandage, run by The Whiteley Clinic.
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 3 inclusion and 11 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Sylvie Hampton, MA (+441323 846850, sylviehampton@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure profile (time frame: 1 day). 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 NCT05178147, which also lists 2 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 5 Jan 2022.