Visit www.kci1.com
Diabetic Foot Wounds Home
V.A.C. Therapy RCT Data Overview

For Positive Healing Outcomes, the Data Speaks for Itself

The highest level of clinical evidence is derived from randomized controlled trials (RCTs). In four RCTs comparing V.A.C. Therapy to control, the conclusions were improved rates of healing.3,5,11,24

In two of these RCTs, V.A.C. Therapy resulted in fewer amputations in patients with diabetic foot wounds.3,5

In an economic analysis of the RCT for diabetic patients with partial foot amputation wounds, V.A.C. Therapy resulted in lower cost of care.2

Blume, et al. Comparison of Negative Pressure Wound Therapy (V.A.C. Therapy) to Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers – a Multicenter Randomized Controlled Trial.
Diabetes Care, 20085

Results5:

  • 335 patients treated: V.A.C. Therapy, 169 patients; AMWT*, 166 patients. All data were calculated at end of 112-day active therapy phase
  • A greater proportion of foot ulcers achieved complete ulcer closure (73/169, 43.2%) vs. AMWT* (48/166, 28.9%; p=0.007)
  • Significantly fewer amputations (7/169, 4.1%) vs. AMWT* (17/166, 10.2%; p=0.035)
  • Kaplan-Meier median time to complete closure (96 days) vs. AMWT* (>112 days; p=0.001)
  • Significantly improved percentage of ulcer closure for patients completing the active treatment phase (73/120, 60.8% vs. AMWT* 48/120, 40%; p=0.001)
  • No significant differences in treatment-related complications.

Armstrong, et al. Negative Pressure Wound Therapy After Partial Diabetic Foot Amputation Negative.
Lancet, 20053

Results3:

  • 162 patients; V.A.C. Therapy, 77 patients; AMWT*, 85 patients. All data were calculated at end of 112-day active therapy phase
  • More patients achieved complete wound closure (43/77, 56%) vs. AMWT* (33/85, 39%; p=-.040)
  • Fewer secondary amputations (2/77; 3%) vs. AMWT* (9/85, 11%; p=0.060)
  • No high-level (above-foot) amputations (0/77, 0%) vs. AMWT* (5/85, 6%)
  • Significantly less time to 76-100% granulation tissue formation (V.A.C. Therapy, 42 days vs. AMWT*, 84 days; p=0.002)
  • Significantly shorter time to complete wound closure (Kaplan-Meier Estimates; p=0.005)
  • Shorter median time to complete wound closure (V.A.C. Therapy, 56 days vs. AMWT*, 77 days)
  • Frequency and severity of adverse events were similar in both treatment groups

Eginton et al. A Prospective Randomized Evaluation of Negative-Pressure Wound Dressings for Diabetic Foot Wounds. Annals of Vascular Surgery 200311

Results11:

  • 10 patients with 11 wounds enrolled: a crossover study design was used with each wound being randomized to receive either moist dressings or V.A.C. Therapy for 2 weeks followed by the alternative dressing for 2 weeks
  • Analysis was based on 6 patients with 7 wounds
  • V.A.C. Therapy significantly decreased wound depth vs. moist dressings (49% reduction vs. 8% reduction; p<0.05)
  • V.A.C. Therapy significantly decreased the wound volume vs. moist dressings (59% reduction vs. 0.1% reduction; p<0.005)

McCallon et al. Vacuum-Assisted Closure versus Saline-Moistened Gauze in the Healing of Postoperative Diabetic Foot Wounds. Ostomy Wound Management, 200024

Results24:

  • 10 patients enrolled: V.A.C. Therapy, 5; Saline-Moistened Gauze (SMG), 5
  • Shorter average time to satisfactory healing: V.A.C. Therapy, 22.8 days vs. SMG, 42.8 days
  • Greater surface area change: V.A.C. Therapy, 28.4% average decrease in wound size vs. SMG, a 9.5% average increase
  • No significant treatment-related adverse events were reported

Apelqvist, et al. Resource Utilization and Economic Costs of Care Based on a Randomized Trial of Vacuum-Assisted Closure Therapy in the Treatment of Diabetic Foot Wounds. The American Journal
of Surgery, 20082

Results2:

  • This economic analysis of the Armstrong RCT data evaluated patients who completed at least 8 weeks of therapy (n = 135 patients). Of these 35% (25 V.A.C. Therapy, 22 AMWT*) received in-patient hospital services during the 112-day active treatment phase.
  • $9,000 average direct cost savings per patient on V.A.C. Therapy
  • 63% fewer mean outpatient visits per patient (V.A.C. Therapy, 4 vs. AMWT*, 11; p<0.05)
  • 65% fewer mean dressing changes (V.A.C. Therapy, 42 vs. AMWT*, 118; p<0.001)
  • 64% fewer overall mean surgical procedures (V.A.C. Therapy, 43 vs. AMWT*, 120; p<0.001)