DHACM vs Other Commercially Available Treatments

This is a prospective, stratified, randomized, controlled, comparative, parallel group, multi-center clinical trial comparing the proportion of ulcers completely healed by use of dehydrated human amnion/chorion membrane (dHACM) placed weekly versus placement of bioengineered skin substitute (BSS) placed weekly, versus standard of care in diabetic patients with a diabetic foot ulcer who have adequate arterial perfusion as defined in section, 2.0 (Patient Eligibility), for wound healing to the affected limb.

Inclusion criteria

• Patients age 18 or older.
• Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
• Patient's ulcer must be diabetic in origin and larger than 1 cm2. Note: Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
• Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• Ulcer must be present for a minimum of four weeks before enrollment/ randomization, with documented failure of conventional ulcer therapy to heal the wound. A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
• Additional wounds may be present but not within 3 cm of the study wound.
• Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
• Patient's ulcer must exhibit no clinical signs of infection.
• Serum Creatinine less than 3.0mg/dl within last six months.
• HbA1c less than or equal to 12% within last 90 days.
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:

• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
• ABIs with results of ≥0.7 and ≤1.2, OR
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg.

Exclusion criteria

• Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
• Patients whose index diabetic foot ulcers are greater than 25 cm2.
• Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
• Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
• Patients with a known history of poor compliance with medical treatments.
• Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
• Patients who are currently receiving radiation therapy or chemotherapy.
• Patients with known or suspected local skin malignancy to the index diabetic ulcer.
• Patients diagnosed with autoimmune connective tissues diseases.
• Non-revascularizable surgical sites.
• Active infection at site.
• Any pathology that would limit the blood supply and compromise healing.
• Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
• Patients who are pregnant or breast feeding.
• Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
• Known allergy to Gentamicin or Streptomycin, or to bovine collagen.
• Patients with known hypersensitivity to components of any treatment used in the trial.
• Wounds greater than one year in duration without intermittent healing.
• Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
• Patients taking Cox-2 inhibitors.
• Planned use of Dakin's solution, Mafenide Acetate, Scarlet Red Dressing, Tincoban, Zinc Sulfate, Povidone Iodine solution, Mafenide Acetate, Polymyxin/Nystatin or Chlorhexidine during trial.