VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic Foot Ulcers (DOLCE)

• Wound closure at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
• Cost effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

• Device: SECONDARY dressing gauze and tape
  SECONDARY dressing gauze and tape
• Procedure: debridement, irrigation
  debridement, irrigation
• Device: Dermagraft™
  Dermagraft™ per company protocol
• Device: Oasis™
  Oasis™ per company protocol

• Active Comparator: Standard of care
  debridement, irrigation , PRIMARY dressing Adaptic® and Iodosorb, SECONDARY dressing gauze and tape
  Interventions:

  • Device: SECONDARY dressing gauze and tape
  • Procedure: debridement, irrigation
• Experimental: Dermagraft™
  debridement, irrigation , PRIMARY dressing Dermagraft™ and Adaptic®, SECONDARY dressing gauze and tape
  Interventions:

  • Device: SECONDARY dressing gauze and tape
  • Procedure: debridement, irrigation
  • Device: Dermagraft™
• Experimental: Oasis™
  debridement, irrigation , PRIMARY dressing Oasis™ and Adaptic®, SECONDARY dressing gauze and tape
  Interventions:

  • Device: SECONDARY dressing gauze and tape
  • Procedure: debridement, irrigation
  • Device: Oasis™

Inclusion Criteria:

(answering NO will exclude patient):

1. An Institutional Review Board (IRB) Informed Consent Form is signed and dated prior to any study-related activities?
2. The area of the study ulcer after debridement is between 1cm2 and 25cm2 at Week 0 / Visit # 3?
3. Is the subject between 18 and 85 years of age?
4. 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)
5. Does the patient have 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.
6. Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon?
7. 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)?
8. Subject has been diagnosed with type 1 or type 2 diabetes and hgbA1c is less than 10%?
9. Study ulcer has no clinical feature of infection? (2 signs of inflammation and elevated bacterial load of the wound)
10. For female subjects of childbearing age potential, does the subject have a negative pregnancy test and is not lactating for the duration of the study?
11. Subject understands the requirements of this study and is willing to comply with all the study requirements?

Exclusion Criteria:

answering YES will exclude patient):

1. Is the subject diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment?
2. Is the patient diagnosed with HIV/AIDS?
3. Is the patient diagnosed with any bleeding disorders?
4. Is the patient diagnosed with any connective tissue diseases?
5. For female subjects, is the subject pregnant or lactating?
6. Does the patient have a history of elicit drug use within one year of enrollment?
7. In the past year, did you experience episodes of drinking more than 5 alcoholic beverages in less than two hours and/or did drinking alcohol become a problem in your interpersonal relationships, work, driving and/or your behavior in general?
8. Does the patient have any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan)?
9. If patient had Doppler exam within the last 365 days, did it demonstrate reflux greater than 0.5 seconds?
10. Is the subject diagnosed with active Charcot as described by Sander's classification system?
11. Does the patient manifest signs of poor nutritional status and/or albumin level < 2.9?
12. Did the patient use Dermagraft™ and/or Oasis™ in the last 60 days?
13. Is the study ulcer size less than 1.0 cm2 or greater than 25 cm2?
14. Does the patient have any porcine allergy or cow product allergy?
15. Does the subject's recent (last 30 days) chemistry tests serum creatinine, 2 times above the upper limit of normal and/or LFT's 3 times above the upper limit of normal?
16. Between week -2/visit 1 and week 0/visit 3 (randomization) did the study ulcer decrease in size by more than 40%, or increase in size by more than 50%?