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

Sponsor

3M (Industry)

Overall Status

Completed

CT.gov ID

NCT00224796

Collaborator

(none)

146

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Device: V.A.C. ® System	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure. []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.