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

Varicose Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02561013
• Other study ID #: 05-013293
• Status: Withdrawn
• Phase: N/A
• First received: September 23, 2015
• Last updated: November 23, 2015
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Is the subject 21 years or older?

2. 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?

3. Does the subject have an ulcer size between 1cm2 and 12cm2?

4. Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?

5. Is the subject ambulatory?

6. 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?

7. Is the subject able to understand questionnaire items and action items (e.g., Subject Diary)?

8. Is the subject willing to give written informed consent, including permission to take photographs of the study leg?

Exclusion Criteria:

1. Does the subject have severe arterial occlusive disease?

2. Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?

3. Does the subject have septic phlebitis?

4. Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?

5. Does the subject have known hypersensitivity to any of the component materials?

6. Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?

7. Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?

8. Does the subject have a hospital stay planned for the 12 weeks following inclusion?

9. Does the subject have a suspected or confirmed cancerous ulceration?

10. Does the subject have severe peripheral sensitive neuropathy?

11. Is the subject participating in any other prospective study interfering with this study?

12. Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?

13. Does the subject have a history of noncompliance to therapies?

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
Canada	Calea Ltd	Mississauga	Ontario
United States	Institute for Advanced Wound Care	Montgomery	Alabama
United States	HealthEast Care System	St. Paul	Minnesota
United States	Jobst Vascular Institute	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
3M

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks		12 weeks	No
Secondary	Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.		Up to 12 weeks	No
Secondary	Relative wound area reduction >/= 40% at Week 4		4 weeks	No
Secondary	Time to complete closure		1-12 weeks	No
Secondary	Occurrence of treatment-related adverse events		0-12 weeks	Yes
Secondary	Occurrence of treatment-related drop-outs		0-12 weeks	No