Juxta-CuresTM Versus Bandaging for Venous Ulcers

NCT02790593 | Completed

• 1 other identifier: Juxta-CuresTM (2016/006)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Ulcer

Outcome Measures

Primary Outcomes (4)

• Number of eligible patients for this study per 100,000 population

  1 year

• Percentage of eligible patients accepted for randomisation

  1 year

• Patient compliance with trial protocol, measured as days without compression in trial period

  1 year

• Percentage of patients completing study

  Those patient completing 6 months of treatment or ulcer healing from all entering study.

  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.

  1 year

• Change in ulcer diameter measured by cm cubed.

  1 year

• Change in ulcer diameter measured by percentage.

  1 year

• Ulcer healing rate

  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

  1 year

Study Arms (2)

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.

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.

Device: Standard Compression; Device: PicoPress®; Device: Silhoutte® 3D wound imaging system

Interventions

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.

Juxta-Cures™

Standard Compression DEVICE

Compression bandaging

Standard compression

PicoPress® DEVICE

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

Juxta-Cures™; Standard compression

Silhoutte® 3D wound imaging system DEVICE

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.

Juxta-Cures™; Standard compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Active venous ulcer for \>2 weeks but \<1 year
• cm 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colchester Hospital University NHS Foundation Trust: lead

Study Sites (1)

NHS Trust

Colchester, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Adam Howard

  Colchester Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Philip Stather

  Colchester Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 6, 2016
• Study Start: January 12, 2017
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)