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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00958711
• Other study ID #: U-0801
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: May 2012

Study information

• Verified date: December 2019
• 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, saline moistened gauze, for the treatment of diabetic foot ulcers.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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

Other:
• Saline and Gauze
gauze moistened with sterile saline

Locations

Country	Name	City	State
United States	Aiyan Diabetes Center	Evans	Georgia
United States	Carolina East Family Medicine	Greenville	North Carolina
United States	Eastern Carolina Foot and Ankle	Greenville	North Carolina
United States	Family Foot & Ankle Physicians	Greenville	North Carolina
United States	Foot and Ankle East	Greenville	North Carolina
United States	Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.	Kinston	North Carolina
United States	University of Miami, Miller School of Medicine	Miami	Florida
United States	The Foot & Ankle Associates of North Carolina, PLLC	Rocky Mount	North Carolina
United States	University of California - San Diego	San Diego	California
United States	Foot & Ankle Associates of Central Illinois, LLC	Springfield	Illinois
United States	Martin Foot and Ankle	York	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	Percentage of Participants Not Healed by Number of Days After Procedure	Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.	Day 20, Day 40, Day 60, Day 80
Primary	Percentage of Participants With Wounds Healed at 12 Weeks		Week 12
Primary	Wound Healing Pathway Markers		Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
Primary	Bacterial Burden		Day 0, Week 1 - Week 12
Secondary	Percentage Mean of Original Wound Size From Baseline by Week	The percent of original wound size was calculated using the following formula: measure at baseline minus measure at follow-up visit divided by measure at baseline. In cases when the baseline depth was reported as 0cm, the minimum non-zero value in the sample (0.1cm) was imputed so a percent reduction measure could be calculated.	Day 0, Week 4, Week 8, Week 12
Secondary	Number of Participants With Ulcer Recurrence		Week 1 to Week 24
Secondary	Number of Device-related Adverse Events (AE)		Week 1 to Week 24
Secondary	Number of Procedure-related Adverse Events (AE)		Week 1 to Week 24
Secondary	Number of Device Failures	Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.	Week 1 to Week 24
Secondary	Number of Device Removals	Device removal is included in device failure under ITT. Subjects who experienced procedure-related events were also device failures under ITT. This endpoint is equivalent to device failure rates reported above.	Week 1 to Week 24
Secondary	Ease of Dressing Use	Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult	Week 1 to Week 12