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

KCI USA, Inc

Status

Completed

Conditions

Diabetic Foot Ulcers

Treatments

Device: Moist Wound Therapy

Device: VAC Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00432965

VAC2001-08

Details and patient eligibility

About

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.

The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.

Enrollment

335 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.