Clinical trial NCT02790593: Juxta-CuresTM Versus Bandaging for Venous Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Lead sponsor: Colchester Hospital University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of eligible patients for this study per 100,000 population
timeFrame: 1 year
measure: Percentage of eligible patients accepted for randomisation
timeFrame: 1 year
measure: Patient compliance with trial protocol, measured as days without compression in trial period
timeFrame: 1 year
measure: Percentage of patients completing study
timeFrame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
Secondary outcomes:
measure: Change in ulcer diameter measured by cm squared.
timeFrame: 1 year
measure: Change in ulcer diameter measured by cm cubed.
timeFrame: 1 year
measure: Change in ulcer diameter measured by percentage.
timeFrame: 1 year
measure: Ulcer healing rate
timeFrame: 1 year (to run entire study including patient recruitment, with each patient enrolled for 6 months)
measure: Patient quality of life measured by EuroQol-5D-5L
timeFrame: 1 year
measure: Patient quality of life measured by VEINESqol/sym
timeFrame: 1 year
measure: Cost effectiveness
timeFrame: 1 year
measure: Pressure consistency
timeFrame: 1 year
Other outcomes:
Locations:
city: Colchester
country: United Kingdom
facility: NHS Trust
Study officials:
affiliation: Colchester Hospital NHS Foundation Trust
name: Adam Howard
role: PRINCIPAL_INVESTIGATOR
affiliation: Colchester Hospital NHS Foundation Trust
name: Philip Stather
role: PRINCIPAL_INVESTIGATOR
References: