Diabetic Foot
Conditions
Keywords
Wound closure, Foot salvage, Accelerated healing, Amputation Wounds of the Diabetic Foot
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 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.
Interventions
DEVICEV.A.C. ® System
Sponsors
KCI USA, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of a diabetic foot amputation wound up to the transmetatarsal region of the foot 2. 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. 3. Age ≥ 18 years of age 4. HbA1c ≤ 12% (collected within the last 90 days.) 5. 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
1. Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group 2. Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency 3. Untreated infection or cellulitis at site of target wound 4. Presence of untreated osteomyelitis 5. Collagen vascular disease 6. Malignancy in the wound 7. Presence of necrotic tissue in the wound 8. Uncontrolled hyperglycemia 9. Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy) 10. Prior V.A.C.® therapy within 30 days. 11. Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (HBO) therapy within 30 days. 12. Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren) 13. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure. | — |
Secondary
| Measure | 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 | — |
Outcome results
None listed