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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: Moist Wound Therapy
* Device: VAC Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAC Therapy<br>Treatment of Diabetic Foot Ulcers with VAC Therapy | Device: VAC Therapy<br>* VAC Therapy<br>* Other names: NPWT;|
| Active Comparator: Moist Wound Therapy<br>Moist Wound Therapy (standard of care) | Device: Moist Wound Therapy<br>* Moist Wound Therapy (Standard of Care)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound closure, Accelerated healing