Venous UlcerJuxta-CuresNCT02790593
Juxta-CuresTM Versus Bandaging for Venous Ulcers
A study testing Juxta-Cures™, Standard Compression and PicoPress® in people with Venous Ulcer, run by Colchester Hospital University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an alternative solution for the long-term treatment of patients with venous ulceration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Juxta-Cures™, Standard Compression and PicoPress®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2017to 29 Jul 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Active venous ulcer for >2 weeks but <1 year
- 1cm squared surface area
- Venous incompetence confirmed by clinical assessment and duplex ultrasound scan
- No evidence of arterial disease (Arterial Duplex or Ankle Brachial Pressure Index >0.9)
- Patients able to complete trial procedures
- Patients with a life expectancy of greater than 1 year
Who cannot join
- Age less than 18 years
- Significant arterial disease (Ankle Brachial Pressure Index <0•9 or evidence on Arterial Duplex)
- Acute Deep Vein Thrombosis
- Patient unable or unwilling to have high compression (30mmHg minimum)
- Patients with dexterity insufficiency of hands
- Patients with peripheral neuropathy
Show all 9Show fewer
- Leg ulcers of another underlying cause
- Leg ulcers of greater than 1 year duration
- Patients unable or unwilling to provide written, informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Clinical Trial Comparing the Effectiveness of Bandaging Compared to the Juxta-CuresTM Device in the Management of People With Venous Ulceration: Feasibility Study
Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging. Secondary outcome measures include whether the Juxta-Cures™ device improves patient compliance and quality of life compared to bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.
Read the detailed description
Participants with lower leg ulceration will be identified at consultant or nurse-led clinics. They will be assessed by their clinician, and identified as having a likely venous ulcer. Participants undergoing current leg ulcer management of any type may be considered for this trial. At this stage participants will be given the most recent version of the patient information sheet, given appropriate initial treatment as determined by their clinician (simple dressings, or compression bandaging if appropriate), and booked for venous and arterial duplex as well as ABPI which will be undertaken within 10 +/- 4 days. The patient will then be reviewed in 10 days +/- 4 days at venous ulcer clinic to discuss any queries regarding the trial with their clinician. Informed consent will be obtained from all participants at this point if appropriate, and the patient will be randomised, (a minimum of 24 hours will be required for the patient to read the information prior to giving informed consent).
Following randomisation the participant will be reviewed in the leg ulcer clinic on a 10 +/- 4 days basis whereby pressure monitoring will be conducted using the PicoPress® (Microlan Italia, Padua, Italy), dressings will be changed and ulcer measured with standard 1cm squared grids, and the Silhoutte® 3D wound imaging system (ARANZ Medical Ltd, Christchurch, New Zealand). Participants will also submit their daily use and pressure diary. The type of dressings applied will also be recorded as well as length of appointment.
50 participants will be recruited (aim for study duration of 12-18 months) from a consultant or nurse-led clinic at Colchester Hospital and associated outlying clinics, and participants randomised to receive either compression bandages or Juxta-Cures™ (bilateral participants will be allocated a single treatment, rather than randomisation of individual limbs). Patients with 'wet' ulcers may receive absorbent dressings under Juxta-Cures™ or compression bandaging during the study period, which will be recorded on the weekly data collection for cost analysis purposes.
At baseline, 1 month, 3 months and 6 months all participants will complete health related quality of life questionnaires. The disease specific VEINESqol/sym, and generic Euroqol-5D-5L surveys will be used, and received positive feedback regarding their content at the patient focus group.
The planned study period for the randomised-control trial is 24 weeks for each participant, but 1 year in total for patient recruitment and analysis.
This study is a feasibility study therefore has not been powered. Following this study the investigators aim to undertake a multi-centre study in collaboration with the Vascular and Endovascular Research Network (VERN), powered to venous ulcer healing at 90% power, using the results of this feasibility study.
- Conditions
- Venous Ulcer
- Being tested
- Juxta-Cures™, Standard Compression, PicoPress®, Silhoutte® 3D wound imaging system
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juxta-Cures™Device
Juxta-CURES™ is an adjustable compression device, which may be used as a secondary dressing for the treatment of open venous stasis ulcers. It is an inelastic wrap around device with a Built-In-Pressure System™, which allows patients to easily and accurately apply pressure to their own leg and adjust it throughout the day.
Standard CompressionDevice
Compression bandaging
PicoPress®Device
Pressure monitoring to be done at time of bandage application and removal for both arms of the study.
Silhoutte® 3D wound imaging systemDevice
Photographic imaging system to measure wound surface area and depth. Picture to be taken at each appointment. This intervention is for both arms of the study.
| Study group | Role | What they receive |
|---|---|---|
| Juxta-Cures™ | Experimental | Patients randomised to the Juxta-Cures™ device. These patients will also have pressure monitoring using the PicoPress device, and ulcer imaging and surface area measurement using the Silhouette system. Receives: Device: Juxta-Cures™; Device: PicoPress®; Device: Silhoutte® 3D wound imaging system |
| Standard compression | Active comparator | Patients randomised to standard compression. These patients will also have pressure monitoring using the PicoPress device, and ulcer imaging and surface area measurement using the Silhouette system. Receives: Device: Standard Compression; Device: PicoPress®; Device: Silhoutte® 3D wound imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible patients for this study per 100,000 population
Measured: 1 year
Percentage of eligible patients accepted for randomisation
Measured: 1 year
Patient compliance with trial protocol, measured as days without compression in trial period
Measured: 1 year
Percentage of patients completing study
Those patient completing 6 months of treatment or ulcer healing from all entering study.
Measured: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
Secondary outcomes (8)
Change in ulcer diameter measured by cm squared.
Measured: 1 year
Change in ulcer diameter measured by cm cubed.
Measured: 1 year
Change in ulcer diameter measured by percentage.
Measured: 1 year
Ulcer healing rate
Percentage of patients with healed ulcers at 6 months
Measured: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
Patient quality of life measured by EuroQol-5D-5L
Aim to determine differences in quality of life using each device
Measured: 1 year
Patient quality of life measured by VEINESqol/sym
Aim to determine differences in quality of life using each device
Measured: 1 year
Cost effectiveness
Total cost of treatment in each arm of the study, measured in pounds sterling
Measured: 1 year
Pressure consistency
Monitor of pressure at bandage application and removal to determine which arm of the trial delivers more consistent pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start12 Jan 2017
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colchester Hospital University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Adam Howard, Principal investigator, Colchester Hospital NHS Foundation TrustPhilip Stather, Principal investigator, Colchester Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790593
- Sponsor's protocol ID
- Juxta-CuresTM (2016/006)
- Acronym
- Juxta-Cures
- Status last verified
- Feb 2020
- First submitted
- 3 May 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Clinical Trial Comparing the Effectiveness of Bandaging Compared to the Juxta-CuresTM Device in the Management of People With Venous Ulceration: Feasibility Study
- ClinicalTrials.gov ID
- NCT02790593
- Acronym / sponsor ID
- Juxta-Cures / Juxta-CuresTM (2016/006)
- Conditions
- Venous Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Colchester Hospital University NHS Foundation TrustOther government
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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.
Venous ulceration is a major burden on the NHS. Current treatment involves bandaging therapy which is replaced on a once or twice weekly basis. The Juxta-CuresTM device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor. The aim of this study is to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging. Secondary outcome measures include whether the Juxta-Cures™ device improves patient compliance and quality of life compared to bandaging, and whether the Juxta-Cures™ device is cost effective compared to bandaging.
Detailed description
Participants with lower leg ulceration will be identified at consultant or nurse-led clinics. They will be assessed by their clinician, and identified as having a likely venous ulcer. Participants undergoing current leg ulcer management of any type may be considered for this trial. At this stage participants will be given the most recent version of the patient information sheet, given appropriate initial treatment as determined by their clinician (simple dressings, or compression bandaging if appropriate), and booked for venous and arterial duplex as well as ABPI which will be undertaken within 10 +/- 4 days. The patient will then be reviewed in 10 days +/- 4 days at venous ulcer clinic to discuss any queries regarding the trial with their clinician. Informed consent will be obtained from all participants at this point if appropriate, and the patient will be randomised, (a minimum of 24 hours will be required for the patient to read the information prior to giving informed consent).
Following randomisation the participant will be reviewed in the leg ulcer clinic on a 10 +/- 4 days basis whereby pressure monitoring will be conducted using the PicoPress® (Microlan Italia, Padua, Italy), dressings will be changed and ulcer measured with standard 1cm squared grids, and the Silhoutte® 3D wound imaging system (ARANZ Medical Ltd, Christchurch, New Zealand). Participants will also submit their daily use and pressure diary. The type of dressings applied will also be recorded as well as length of appointment.
50 participants will be recruited (aim for study duration of 12-18 months) from a consultant or nurse-led clinic at Colchester Hospital and associated outlying clinics, and participants randomised to receive either compression bandages or Juxta-Cures™ (bilateral participants will be allocated a single treatment, rather than randomisation of individual limbs). Patients with 'wet' ulcers may receive absorbent dressings under Juxta-Cures™ or compression bandaging during the study period, which will be recorded on the weekly data collection for cost analysis purposes.
At baseline, 1 month, 3 months and 6 months all participants will complete health related quality of life questionnaires. The disease specific VEINESqol/sym, and generic Euroqol-5D-5L surveys will be used, and received positive feedback regarding their content at the patient focus group.
The planned study period for the randomised-control trial is 24 weeks for each participant, but 1 year in total for patient recruitment and analysis.
This study is a feasibility study therefore has not been powered. Following this study the investigators aim to undertake a multi-centre study in collaboration with the Vascular and Endovascular Research Network (VERN), powered to venous ulcer healing at 90% power, using the results of this feasibility study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juxta-Cures™ | Experimental | Device: Juxta-Cures™, Device: PicoPress®, Device: Silhoutte® 3D wound imaging systemPatients randomised to the Juxta-Cures™ device. These patients will also have pressure monitoring using the PicoPress device, and ulcer imaging and surface area measurement using the Silhouette system. |
| Standard compression | Active comparator | Device: Standard Compression, Device: PicoPress®, Device: Silhoutte® 3D wound imaging systemPatients randomised to standard compression. These patients will also have pressure monitoring using the PicoPress device, and ulcer imaging and surface area measurement using the Silhouette system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years old
- Active venous ulcer for >2 weeks but <1 year
Key exclusion criteria (9 listed)
- Age less than 18 years
- Significant arterial disease (Ankle Brachial Pressure Index <0•9 or evidence on Arterial Duplex)
- Acute Deep Vein Thrombosis
- Patient unable or unwilling to have high compression (30mmHg minimum)
- Patients with dexterity insufficiency of hands
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 |
|---|---|---|
| Juxta-Cures™Juxta-CURES™ is an adjustable compression device, which may be used as a secondary dressing for the treatment of open venous stasis ulcers. It is an inelastic wrap around device with a Built-In-Pressure System™, which allows patients to easily and accurately apply pressure to their own leg and adjust it throughout the day. | Device | Juxta-Cures™ |
| Standard CompressionCompression bandaging | Device | Standard compression |
| PicoPress®Pressure monitoring to be done at time of bandage application and removal for both arms of the study. | Device | Juxta-Cures™, Standard compression |
| Silhoutte® 3D wound imaging systemPhotographic imaging system to measure wound surface area and depth. Picture to be taken at each appointment. This intervention is for both arms of the study. | Device | Juxta-Cures™, Standard compression |
Primary outcome
Number of eligible patients for this study per 100,000 population
Time frame: 1 year
Percentage of eligible patients accepted for randomisation
Time frame: 1 year
Patient compliance with trial protocol, measured as days without compression in trial period
Time frame: 1 year
Percentage of patients completing study
Time frame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
Those patient completing 6 months of treatment or ulcer healing from all entering study.
8 secondary outcomes
Change in ulcer diameter measured by cm squared.
Time frame: 1 year
Change in ulcer diameter measured by cm cubed.
Time frame: 1 year
Change in ulcer diameter measured by percentage.
Time frame: 1 year
Ulcer healing rate
Time frame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
Patient quality of life measured by EuroQol-5D-5L
Time frame: 1 year
Patient quality of life measured by VEINESqol/sym
Time frame: 1 year
Cost effectiveness
Time frame: 1 year
Pressure consistency
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Adam Howard principal investigator
Colchester Hospital NHS Foundation Trust
Philip Stather principal investigator
Colchester Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juxta-Cures™, Standard Compression and PicoPress® in people with Venous Ulcer, run by Colchester Hospital University NHS Foundation Trust 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: finished, as of the sponsor's last update on 12 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible patients for this study per 100,000 population (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2020.