Status:
COMPLETED
VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
VA Northern California Health Care System
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers...
Eligibility Criteria
Inclusion
- (Answering NO will exclude patient):
- An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
- The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
- Subjects between 18 and 85 years of age.
- Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.6.
- The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.
- Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
- Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
- Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
- Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
- For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
- Subject understands the requirements of this study and is willing to comply with all the study requirements.
Exclusion
- (Answering YES will exclude patient):
- The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
- The subject is diagnosed with HIV/AIDS.
- The subject is diagnosed with any bleeding disorders.
- The subject is diagnosed with any connective tissue diseases.
- For female subjects, the subject is pregnant or lactating.
- The subject has a history of illicit drug use within one year of enrollment.
- In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
- The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
- Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
- The subject is diagnosed with active Charcot as described by Saunder's classification system.
- The subject manifests signs of poor nutritional status and/or albumin level \< 2.9.
- The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.
- The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.
- The subject has any porcine allergy or cow product allergy.
- The subject's recent (last 30 days) chemistry tests serum creatinine is 2 times above the upper limit of normal and/or LFT's 3 times above the upper limit of normal.
- Between Visit 1/Week -2 and Visit 3/Week 0 (randomization) the study ulcer has decreased in size by more than 40%, or increased in size by more than 50%.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01450943
Start Date
October 1 2011
End Date
April 4 2018
Last Update
September 17 2019
Active Locations (1)
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1
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655