Clinical trial NCT00953563: The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
Official title: The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Venous Leg Ulcers
Keywords: Venous Leg Ulcers
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2009-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound healing pathway markers
timeFrame: baseline, day 0, 3, wk 1, 2
Secondary outcomes:
measure: Bacterial Bioburder
timeFrame: baseline, day 0, 3, wk 1, 2
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Warren
country: United States
facility: Newbridge Medical Research Corp., Warren General Hosp.
state: Pennsylvania
Study officials:
affiliation: UCSD
name: Gerit Mulder, DPM
role: PRINCIPAL_INVESTIGATOR
References: