Clinical trial NCT01450943: VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic
Official title: A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Chronic wounds
Chronic ulcers
Oasis
Dermagraft
Adaptic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Northern California Health Care System
First posted: 2011-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Our hypothesis is that these devices are of equal efficacy.


Eligibility criteria: Inclusion Criteria:

(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 Criteria:

(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%.

Primary outcomes:
measure: Wound Closure by Week 15
timeFrame: 15 weeks
Secondary outcomes:
measure: Wound Closure at 20 Weeks
timeFrame: 20 weeks
measure: Cost Effectiveness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Rivkah R. Isseroff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lev-Tov H, Li CS, Dahle S, Isseroff RR. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial. Trials. 2013 Jan 9;14:8. doi: 10.1186/1745-6215-14-8.