Clinical trial NCT00432965: Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
Official title: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: Wound closure
Accelerated healing
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Complete Ulcer Closure Closure.
timeFrame: Days 0-114
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Tucson Vascular Surgery, PLLC
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Medical Center, Dept. Surgery
state: Arizona
city: Castro Valley
country: United States
facility: Bay Area Foot Care
state: California
city: Los Angeles
country: United States
facility: Innovative Medical Technologies
state: California
city: Santa Rosa
country: United States
facility: Walter F. D Costa
state: California
city: Greeley
country: United States
facility: Banner Health at North Colorado Med. Ctr
state: Colorado
city: New Haven
country: United States
facility: North American Center for Limb Preservation
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Boca Raton
country: United States
facility: Podiatric Success, Inc.
state: Florida
city: Atlanta
country: United States
facility: Aim Research
state: Georgia
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
city: North Chicago
country: United States
facility: North Chicago VAMC
state: Illinois
city: North Chicago
country: United States
facility: Rosalind Franklin University
state: Illinois
city: Des Moines
country: United States
facility: Des Moines University
state: Iowa
city: New York
country: United States
facility: St. Lukes Roosevelt
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Circleville
country: United States
facility: Circleville Foot and Ankle, LLC
state: Ohio
city: Zanesville
country: United States
facility: Genesis Health Care System
state: Ohio
city: Brownsville
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: San Antonio
country: United States
facility: Robert Wunderlich, DPM
state: Texas
city: San Antonio
country: United States
facility: Abbott Clinical Research, Inc.
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Hospital
state: Washington
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: North American Center for Limb Preservation
name: Peter Blume, DPM
role: PRINCIPAL_INVESTIGATOR
References: