A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers

Withdrawn before enrolling · Not applicable

Conditions studied: Varicose Ulcer

In brief

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

Key facts

Study ID

NCT02561013

Run by

3M

People needed

0

Starts

2015-09-01

Expected to finish

2016-03-01

Last updated by the study team

2015-11-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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?

You may not qualify if…

• 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?
• Is the subject participating in any other prospective study interfering with this study?
• Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?
• Does the subject have a history of noncompliance to therapies?

Where it is running

• HealthEast Care System — Saint Paul, Minnesota, United States
• Jobst Vascular Institute — Toledo, Ohio, United States
• Lawson Health Research Institute — London, Ontario, Canada
• Calea Ltd — Mississauga, Ontario, Canada
• Institute for Advanced Wound Care — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.