- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790593
Juxta-CuresTM Versus Bandaging for Venous Ulcers (Juxta-Cures)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colchester, United Kingdom
- NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Leg ulcers of another underlying cause
- Leg ulcers of greater than 1 year duration
- Patients unable or unwilling to provide written, informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Juxta-Cures™
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.
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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.
Pressure monitoring to be done at time of bandage application and removal for both arms of the study.
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.
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Active Comparator: Standard compression
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.
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Pressure monitoring to be done at time of bandage application and removal for both arms of the study.
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.
Compression bandaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of eligible patients for this study per 100,000 population
Time Frame: 1 year
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1 year
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Percentage of eligible patients accepted for randomisation
Time Frame: 1 year
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1 year
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Patient compliance with trial protocol, measured as days without compression in trial period
Time Frame: 1 year
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1 year
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Percentage of patients completing study
Time Frame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
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Those patient completing 6 months of treatment or ulcer healing from all entering study.
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1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ulcer diameter measured by cm squared.
Time Frame: 1 year
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1 year
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Change in ulcer diameter measured by cm cubed.
Time Frame: 1 year
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1 year
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Change in ulcer diameter measured by percentage.
Time Frame: 1 year
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1 year
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Ulcer healing rate
Time Frame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
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Percentage of patients with healed ulcers at 6 months
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1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
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Patient quality of life measured by EuroQol-5D-5L
Time Frame: 1 year
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Aim to determine differences in quality of life using each device
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1 year
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Patient quality of life measured by VEINESqol/sym
Time Frame: 1 year
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Aim to determine differences in quality of life using each device
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1 year
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Cost effectiveness
Time Frame: 1 year
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Total cost of treatment in each arm of the study, measured in pounds sterling
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1 year
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Pressure consistency
Time Frame: 1 year
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Monitor of pressure at bandage application and removal to determine which arm of the trial delivers more consistent pressure
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Adam Howard, Colchester Hospital NHS Foundation Trust
- Principal Investigator: Philip Stather, Colchester Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Juxta-CuresTM (2016/006)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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