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

NCT02561013 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-11-25

No results posted yet for this study

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.

Conditions

  • Varicose Ulcer

Interventions

DEVICE

3M™ Coban™ Custom Fit Compression System

3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve. The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together.

DEVICE

Profore

PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.

Sponsors & Collaborators

  • 3M

    lead INDUSTRY

Principal Investigators

  • Patrick J Parks, MD, PhD · 3M Critical & Chronic Care Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States
  • Canada

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 NCT02561013 on ClinicalTrials.gov