Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.

Official Title
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A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: V.A.C. ® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot 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 Ankle brachial index (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 (case report forms)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 Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency Untreated infection or cellulitis at site of target wound Presence of untreated osteomyelitis Collagen vascular disease Malignancy in the wound Presence of necrotic tissue in the wound Uncontrolled hyperglycemia Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy) Prior V.A.C.® therapy within 30 days. Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (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: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.

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

| Intervention/Treatment |
| --- |
|Device: V.A.C. ® System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure |  |  | 
| To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study |  |  | 
| To determine the change in wound area over time |  |  | 
| To determine the incidence of complications |  |  | 
| To determine the effect of V.A.C. ® Therapy on the quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot salvage, Accelerated healing, Wound closure, Amputation Wounds of the Diabetic Foot