Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

Inclusion Criteria: * Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.) * DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E) * Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg. * Age ≥ 18 years of age * HbA1c ≤ 12% (collected within the last 90 days.) * Evidence of adequate nutrition by one of the following: * Lab results reflecting Pre-Albumin \>16 mg/dl and Albumin level is \>3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. Proper documentation on CRFs is needed. Exclusion Criteria: * Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group * Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency * Untreated infection or cellulites at site of target ulcer * Presence of untreated osteomyelitis * Collagen vascular disease * Malignancy in the ulcer * Presence of necrotic tissue * Uncontrolled hyperglycemia * Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy) * Open amputations * Prior V.A.C. therapy within 30 days. * Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days. * Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren) * Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days. * Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study * Pregnant or nursing mothers.