va merit: a comparative efficacy study: treatment of non-healing diabetic

Conditions: Diabetic Foot Ulcer

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%.

Keywords: diabetic foot ulcer chronic wounds chronic ulcers oasis dermagraft adaptic