The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

NCT00958711

Diabetic Foot Ulcers

TERMINATED NA

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

NCT02561013

Varicose Ulcer

WITHDRAWN NA

Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

NCT05962931

Venous Ulcer

UNKNOWN PHASE1/PHASE2

A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers

NCT00235209

Leg Ulcer

COMPLETED PHASE4

Preliminary Testing of New Treatment for Chronic Leg Wounds

NCT00000431

Varicose Ulcer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Venous Leg Ulcers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

compression therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Biologic with compression therapy

Group Type ACTIVE_COMPARATOR

Unite Biomatrix

Intervention Type DEVICE

collagen based, decellularized equine pericardial dressing for skin surface wounds

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Unite Biomatrix

collagen based, decellularized equine pericardial dressing for skin surface wounds

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No