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

NCT ID: NCT00432965

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2008-03-31

Brief Summary

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.

Conditions

Diabetic Foot Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VAC Therapy

Treatment of Diabetic Foot Ulcers with VAC Therapy

Group Type: EXPERIMENTAL

VAC Therapy

Intervention Type: DEVICE

VAC Therapy

Moist Wound Therapy

Moist Wound Therapy (standard of care)

Group Type: ACTIVE_COMPARATOR

Moist Wound Therapy

Intervention Type: DEVICE

Moist Wound Therapy (Standard of Care)

Interventions

Moist Wound Therapy

Moist Wound Therapy (Standard of Care)

Intervention Type: DEVICE

VAC Therapy

VAC Therapy

Intervention Type: DEVICE

Other Intervention Names

NPWT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCI USA, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Blume, DPM

Role: PRINCIPAL_INVESTIGATOR

North American Center for Limb Preservation

Locations

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

Countries

United States; Canada

Other Identifiers

VAC2001-08

Identifier Type: -

Identifier Source: org_study_id