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Juxta-CuresTM Versus Bandaging for Venous Ulcers (Juxta-Cures)

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ClinicalTrials.gov Identifier: NCT02790593
Recruitment Status : Unknown
Verified March 2017 by Colchester Hospital University NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : June 6, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Colchester Hospital University NHS Foundation Trust

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Venous Ulcer Device: Juxta-Cures™ Device: Standard Compression Device: PicoPress® Device: Silhoutte® 3D wound imaging system Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2018

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.
Device: 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: PicoPress®
Pressure monitoring to be done at time of bandage application and removal for both arms of the study.

Device: Silhoutte® 3D wound imaging system
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.

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.
Device: Standard Compression
Compression bandaging

Device: PicoPress®
Pressure monitoring to be done at time of bandage application and removal for both arms of the study.

Device: Silhoutte® 3D wound imaging system
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.




Primary Outcome Measures :
  1. Number of eligible patients for this study per 100,000 population [ Time Frame: 1 year ]
  2. Percentage of eligible patients accepted for randomisation [ Time Frame: 1 year ]
  3. Patient compliance with trial protocol, measured as days without compression in trial period [ Time Frame: 1 year ]
  4. 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.


Secondary Outcome Measures :
  1. Change in ulcer diameter measured by cm squared. [ Time Frame: 1 year ]
  2. Change in ulcer diameter measured by cm cubed. [ Time Frame: 1 year ]
  3. Change in ulcer diameter measured by percentage. [ Time Frame: 1 year ]
  4. Ulcer healing rate [ Time Frame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months) ]
    Percentage of patients with healed ulcers at 6 months

  5. Patient quality of life measured by EuroQol-5D-5L [ Time Frame: 1 year ]
    Aim to determine differences in quality of life using each device

  6. Patient quality of life measured by VEINESqol/sym [ Time Frame: 1 year ]
    Aim to determine differences in quality of life using each device

  7. Cost effectiveness [ Time Frame: 1 year ]
    Total cost of treatment in each arm of the study, measured in pounds sterling

  8. Pressure consistency [ Time Frame: 1 year ]
    Monitor of pressure at bandage application and removal to determine which arm of the trial delivers more consistent pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790593


Contacts
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Contact: Ayres Caldeira +44 (0) 1206745247 Ayres.Caldeira@colchesterhospital.nhs.uk
Contact: Seema Gopinath +44 (0) 01206745249 Seema.Gopinath@colchesterhospital.nhs.uk

Locations
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United Kingdom
NHS Trust Recruiting
Colchester, United Kingdom
Contact: Debbie Campbell    01206745246      
Contact: Ayres Caldeira    01206745247      
Principal Investigator: Adam Howard         
Sponsors and Collaborators
Colchester Hospital University NHS Foundation Trust
Investigators
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Principal Investigator: Adam Howard Colchester Hospital NHS Foundation Trust
Principal Investigator: Philip Stather Colchester Hospital NHS Foundation Trust

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Responsible Party: Colchester Hospital University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02790593     History of Changes
Other Study ID Numbers: Juxta-CuresTM (2016/006)
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases