A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers

3M5 sites in 2 countriesSeptember 2015

ConditionsVaricose Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Varicose Ulcer
Sponsor: 3M
Locations: 5
Primary Endpoint: The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers.

Detailed Description

The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers. The new compression system consists of a compression stocking and and adjustable compression sleeve. It will be used over primary dressings to provide compression that is beneficial to the healing of venous leg ulcers.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is the subject 21 years or older?
•Does the subject have an active venous leg ulceration? If multiple ulcers are present, the investigator will need to select a single ulcer of the study leg that is \> 2cm apart from any other ulcer?
•Does the subject have an ulcer size between 1cm2 and 12cm2?
•Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?
•Is the subject ambulatory?
•Is the subject or family member willing to self-manage the venous leg ulcer therapy at home in collaboration with the medical staff, including the ability to properly readjust the closure straps as indicated by tension indicators, and apply new dressings when needed?
•Is the subject able to understand questionnaire items and action items (e.g., Subject Diary)?
•Is the subject willing to give written informed consent, including permission to take photographs of the study leg?

Exclusion Criteria

•Does the subject have severe arterial occlusive disease?
•Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
•Does the subject have septic phlebitis?
•Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
•Does the subject have known hypersensitivity to any of the component materials?
•Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?
•Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?
•Does the subject have a hospital stay planned for the 12 weeks following inclusion?
•Does the subject have a suspected or confirmed cancerous ulceration?
•Does the subject have severe peripheral sensitive neuropathy?

Outcomes

Primary Outcomes

The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks

Time Frame: 12 weeks

Secondary Outcomes

Occurrence of treatment-related adverse events(0-12 weeks)
Time to complete closure(1-12 weeks)
Occurrence of treatment-related drop-outs(0-12 weeks)
Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.(Up to 12 weeks)
Relative wound area reduction >/= 40% at Week 4(4 weeks)