The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Venous Leg Ulcers Clinical Trial

Official title:

The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00953563
• Other study ID #: U0802
• Status: Withdrawn
• Phase: N/A
• First received: July 24, 2009
• Last updated: April 4, 2017
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Device:
• Unite Biomatrix
collagen based, decellularized equine pericardial dressing for skin surface wounds

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Synovis Surgical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing pathway markers		baseline, day 0, 3, wk 1, 2
Secondary	Bacterial Bioburder		baseline, day 0, 3, wk 1, 2