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

Diabetic Foot Ulcers Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432965
• Other study ID #: VAC2001-08
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Est. completion date: March 2008

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• Moist Wound Therapy
Moist Wound Therapy (Standard of Care)
• VAC Therapy
VAC Therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
3M

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Complete Ulcer Closure Closure.		Days 0-114