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

NCT00432965 | Completed Results

• 1 other identifier: VAC2001-08
• Study Type: interventional
• Target: 335
• Locations: 2 countries
• Sites: 25

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

Keywords

Wound closure; Accelerated healing

Outcome Measures

Primary Outcomes (1)

• Incidence of Complete Ulcer Closure Closure.

  Days 0-114

Study Arms (2)

VAC Therapy

EXPERIMENTAL

Treatment of Diabetic Foot Ulcers with VAC Therapy

Device: VAC Therapy

Moist Wound Therapy

ACTIVE COMPARATOR

Moist Wound Therapy (standard of care)

Device: Moist Wound Therapy

Interventions

Moist Wound Therapy DEVICE

Moist Wound Therapy (Standard of Care)

Moist Wound Therapy

VAC Therapy DEVICE

VAC Therapy

Also known as: NPWT

VAC Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (25)

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Hope Research Institute

Phoenix, Arizona, 85015, United States

Location

Tucson Vascular Surgery, PLLC

Tucson, Arizona, 85704, United States

Location

Southern Arizona VA Medical Center, Dept. Surgery

Tucson, Arizona, 85723, United States

Location

Bay Area Foot Care

Castro Valley, California, 94546, United States

Location

Innovative Medical Technologies

Los Angeles, California, 90063, United States

Location

Walter F. D Costa

Santa Rosa, California, 95403, United States

Location

Banner Health at North Colorado Med. Ctr

Greeley, Colorado, 80634, United States

Location

North American Center for Limb Preservation

New Haven, Connecticut, 06515, United States

Location

Bay Pines VA Medical Center

Bay Pines, Florida, 33744, United States

Location

Podiatric Success, Inc.

Boca Raton, Florida, 33486, United States

Location

Aim Research

Atlanta, Georgia, 30350, United States

Location

Hines VA Hospital

Hines, Illinois, 60141, United States

Location

North Chicago VAMC

North Chicago, Illinois, 60064, United States

Location

Rosalind Franklin University

North Chicago, Illinois, 60064, United States

Location

Des Moines University

Des Moines, Iowa, 50312, United States

Location

St. Lukes Roosevelt

New York, New York, 10019, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Circleville Foot and Ankle, LLC

Circleville, Ohio, 43113, United States

Location

Genesis Health Care System

Zanesville, Ohio, 43701, United States

Location

Valley Baptist Medical Center

Brownsville, Texas, 78520, United States

Location

Robert Wunderlich, DPM

San Antonio, Texas, 78212, United States

Location

Abbott Clinical Research, Inc.

San Antonio, Texas, 78224, United States

Location

Madigan Army Hospital

Tacoma, Washington, 98431, United States

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Sr Director, Global Clinical Development
• Organization: Acelity

jane.hart@kci1.com

210-255-5595

Study Officials

• Peter Blume, DPM

  North American Center for Limb Preservation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 8, 2007
• Study Start: May 1, 2002
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 16, 2024
• Results First Posted: November 13, 2017

Record last verified: 2024-10

Locations

CA (1); US (24)