Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot

Inclusion criteria

• Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot
• 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
• Ankle brachial index (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 (case report forms)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
• Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency
• Untreated infection or cellulitis at site of target wound
• Presence of untreated osteomyelitis
• Collagen vascular disease
• Malignancy in the wound
• Presence of necrotic tissue in the wound
• Uncontrolled hyperglycemia
• Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
• Prior V.A.C.® therapy within 30 days.
• Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (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: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.