|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00958711 |
|
Date of registration:
|
11/08/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
|
|
Scientific title:
|
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00958711 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetic Foot Ulcers
|
|
Intervention(s)
|
|
Device: Unite Biomatrix
|
|
Other: Saline and Gauze
|
|
Primary Outcome(s)
|
|
Percentage of Participants Not Healed by Number of Days After Procedure
[Time Frame: Day 20, Day 40, Day 60, Day 80]
|
|
Bacterial Burden
[Time Frame: Day 0, Week 1 - Week 12]
|
|
Percentage of Participants With Wounds Healed at 12 Weeks
[Time Frame: Week 12]
|
|
Wound Healing Pathway Markers
[Time Frame: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4]
|
|
Secondary Outcome(s)
|
|
Number of Device Failures
[Time Frame: Week 1 to Week 24]
|
|
Number of Device Removals
[Time Frame: Week 1 to Week 24]
|
|
Number of Device-related Adverse Events (AE)
[Time Frame: Week 1 to Week 24]
|
|
Ease of Dressing Use
[Time Frame: Week 1 to Week 12]
|
|
Number of Participants With Ulcer Recurrence
[Time Frame: Week 1 to Week 24]
|
|
Number of Procedure-related Adverse Events (AE)
[Time Frame: Week 1 to Week 24]
|
|
Percentage Mean of Original Wound Size From Baseline by Week
[Time Frame: Day 0, Week 4, Week 8, Week 12]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|