The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Not Applicable

Withdrawn

• Conditions: Venous Leg Ulcers
• Interventions: Device: Unite Biomatrix

• Registration Number: NCT00953563
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• venous ulcer confirmed w/ duplex ultrasound

• ulcer greater than 6 months duration

• post-debridement, the ulcer size must be >5cm2

• at least 18 years old

• ABI is between 0.7 to 1.2 and/or one of the following:

  • TcPO2 > 30mmHg at the ankle
  • Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)

• able and willing to provide a voluntary written informed consent

• three or fewer ulcers separated by >3.0 cm distance

• able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria

• greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator
• ulcer with exposed bone or tendon
• clinical infection at the studied ulcer site including cellulitis and osteomyelitis
• ulcer of a non-venous insufficiency etiology
• phlebitis or deep leg vein thrombosis in past 30 days
• arterial bypass in previous 30 days
• severe anemia (Hgb<8)
• serum albumin <3.0
• uncompensated congestive heart failure
• renal failure with Creatinine >2.5mg/dl
• rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
• severe liver disease as defined by treating physician
• uncontrolled diabetes mellitus determined by treating physician
• malignancy at or near the ulcer site
• any condition judged by the PI that would cause the study to be detrimental to the patient
• known allergy to equine derived tissue
• received another investigational device or drug within 30 days of Day 0
• radiation therapy at the wound site
• chemotherapy or immunosuppressive therapy within 30 days of enrollment
• received another allograft, autograft, xenograft within 30 days of the study
• pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biologic with compression therapy	Unite Biomatrix	-

Primary Outcome Measures

Name	Time	Method
Wound healing pathway markers	baseline, day 0, 3, wk 1, 2

Secondary Outcome Measures

Name	Time	Method
Bacterial Bioburder	baseline, day 0, 3, wk 1, 2

Trial Locations

Locations (3)

University of Miami, Miller School of Medicine; 🇺🇸 Miami, Florida, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Newbridge Medical Research Corp., Warren General Hosp.; 🇺🇸 Warren, Pennsylvania, United States