Trials / Withdrawn
WithdrawnNCT02561013
A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- 3M · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2015-09-25
- Last updated
- 2015-11-25
Locations
5 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02561013. Inclusion in this directory is not an endorsement.