Status:
COMPLETED
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
Lead Sponsor:
KCI USA, Inc
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00224796
Start Date
May 1 2002
End Date
October 1 2005
Last Update
December 2 2024
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