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

Baxter

Status: Terminated

Conditions: Diabetic Foot Ulcers

Treatments: Device: Unite Biomatrix; Other: Saline and Gauze

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958711

U-0801

Details and patient eligibility

About

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, saline moistened gauze, for the treatment of diabetic foot ulcers.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).

2. Diagnosis of diabetes mellitus (type I or II) adequately controlled.

3. The ulcer is greater than 4 weeks duration.

4. Three or fewer ulcers separated by > 3.0 cm distance.

5. Post-debridement, the ulcer size must be between 1 and 10 sq cm2.

6. Ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present:

   • transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
   • toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)

7. At least 18 years old.

8. Able and willing to provide a voluntary written informed consent.

9. Able and willing to wear an off-loading orthopedic shoe.

10. Able and willing to attend scheduled follow-up visits and study related exams.

Exclusion criteria

1. Greater than 30% reduction in wound size during first week of observation by the investigator.
2. Ulcer with exposed tendon or bone.
3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
4. Gangrene.
5. Active Charcot's disease as determined by clinical and radiographic examination.
6. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
7. Known severe anemia.
8. Known serum albumin < 2.5.
9. Renal failure with Creatinine > 2.5.
10. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
11. Severe liver disease as defined by the treating physician or patient's primary care physician.
12. Malignancy at or near the ulcer site.
13. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
14. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
15. Received another investigational device or drug within 30 days of Day 0.
16. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
17. Received another allograft, autograft or xenograft within 30 days of the Day 0.
18. Known allergy to equine derived tissue.
19. Alcohol or drug abuse, defined as current medical treatment for substance abuse.
20. Pregnant or nursing women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Biologic - Unite Biomatrix

Experimental group

Treatment:

Device: Unite Biomatrix

Saline and Gauze

Active Comparator group

Treatment:

Other: Saline and Gauze