Clinical trial NCT02561013: A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
Official title: A Randomized, Controlled, Clinical Study to Assess a New Adjustable Compression Device in Patients With Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Varicose Ulcer
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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?

Primary outcomes:
measure: The primary efficacy endpoint is the number of ulcers achieving complete closure (100% epithelialization) after 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound area reduction and relative wound area reduction at weeks 4, 8, and 12.
timeFrame: Up to 12 weeks
measure: Relative wound area reduction >/= 40% at Week 4
timeFrame: 4 weeks
measure: Time to complete closure
timeFrame: 1-12 weeks
measure: Occurrence of treatment-related adverse events
timeFrame: 0-12 weeks
measure: Occurrence of treatment-related drop-outs
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: St. Paul
country: United States
facility: HealthEast Care System
state: Minnesota
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Mississauga
country: Canada
facility: Calea Ltd
state: Ontario
Study officials:
affiliation: 3M Critical & Chronic Care Division
name: Patrick J Parks, MD, PhD
role: STUDY_DIRECTOR
References: