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Juxta-CuresTM Versus Bandaging for Venous Ulcers

NCT02790593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-12

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Colchester Hospital University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Adam Howard · Colchester Hospital NHS Foundation Trust

  • Philip Stather · Colchester Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-12
Primary Completion
2019-07-29
Completion
2019-07-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790593 on ClinicalTrials.gov