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

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT00432965

Run by

KCI USA, Inc

People needed

335

Starts

2002-05-01

Expected to finish

2008-03-01

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• Tucson Vascular Surgery, PLLC — Tucson, Arizona, United States
• Southern Arizona VA Medical Center, Dept. Surgery — Tucson, Arizona, United States
• Bay Area Foot Care — Castro Valley, California, United States
• Innovative Medical Technologies — Los Angeles, California, United States
• Walter F. D Costa — Santa Rosa, California, United States
• Banner Health at North Colorado Med. Ctr — Greeley, Colorado, United States
• North American Center for Limb Preservation — New Haven, Connecticut, United States
• Bay Pines VA Medical Center — Bay Pines, Florida, United States
• Podiatric Success, Inc. — Boca Raton, Florida, United States
• Aim Research — Atlanta, Georgia, United States
• Hines VA Hospital — Hines, Illinois, United States
• North Chicago VAMC — North Chicago, Illinois, United States
• Rosalind Franklin University — North Chicago, Illinois, United States
• Des Moines University — Des Moines, Iowa, United States
• St. Lukes Roosevelt — New York, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• Circleville Foot and Ankle, LLC — Circleville, Ohio, United States
• Genesis Health Care System — Zanesville, Ohio, United States
• Valley Baptist Medical Center — Brownsville, Texas, United States
• Robert Wunderlich, DPM — San Antonio, Texas, United States
• Abbott Clinical Research, Inc. — San Antonio, Texas, United States
• Madigan Army Hospital — Tacoma, Washington, United States
• St. Boniface General Hospital — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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