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

KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: VAC Therapy; Device: Moist Wound Therapy

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
    • Phoenix, Arizona, United States, 85015
      • Hope Research Institute
    • Tucson, Arizona, United States, 85704
      • Tucson Vascular Surgery, PLLC
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Medical Center, Dept. Surgery
  • California
    • Castro Valley, California, United States, 94546
      • Bay Area Foot Care
    • Los Angeles, California, United States, 90063
      • Innovative Medical Technologies
    • Santa Rosa, California, United States, 95403
      • Walter F. D Costa
  • Colorado
    • Greeley, Colorado, United States, 80634
      • Banner Health at North Colorado Med. Ctr
  • Connecticut
    • New Haven, Connecticut, United States, 06515
      • North American Center for Limb Preservation
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Medical Center
    • Boca Raton, Florida, United States, 33486
      • Podiatric Success, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30350
      • Aim Research
  • Illinois
    • Hines, Illinois, United States, 60141
      • Hines VA Hospital
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University
    • North Chicago, Illinois, United States, 60064
      • North Chicago VAMC
  • Iowa
    • Des Moines, Iowa, United States, 50312
      • Des Moines University
  • New York
    • New York, New York, United States, 10019
      • St. Lukes Roosevelt
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Circleville, Ohio, United States, 43113
      • Circleville Foot and Ankle, LLC
    • Zanesville, Ohio, United States, 43701
      • Genesis Health Care System
  • Texas
    • Brownsville, Texas, United States, 78520
      • Valley Baptist Medical Center
    • San Antonio, Texas, United States, 78212
      • Robert Wunderlich, DPM
    • San Antonio, Texas, United States, 78224
      • Abbott Clinical Research, Inc.
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAC Therapy; Treatment of Diabetic Foot Ulcers with VAC Therapy	Device: VAC Therapy; VAC Therapy; Other Names: NPWT
Active Comparator: Moist Wound Therapy; Moist Wound Therapy (standard of care)	Device: Moist Wound Therapy; Moist Wound Therapy (Standard of Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Complete Ulcer Closure Closure.	Days 0-114

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Peter Blume, DPM, North American Center for Limb Preservation

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 6, 2007
• First Submitted That Met QC Criteria: February 6, 2007
• First Posted (Estimate): February 8, 2007

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Wound closure; Accelerated healing
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: VAC2001-08