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.