59.2 Interim results of a randomized, controlled multicenter trial of vacuum-assisted closure therapy* in the treatment and blinded evaluation of diabetic foot ulcers

Peter A. Blume, DPM¹; Bauer E. Sumpio, MD, PhD²; ¹North American Center for Limb Preservation, ²Dept of Vascular Surgery, Yale University School of Medicine; Wyatt Payne, MD

Background: Diabetic foot ulcers are a menacing ramification endured by many affected with the disease. The research objective was to evaluate the clinical effectiveness and safety of Negative Pressure Wound Therapy (V.A.C.® Therapy*) versus standard moist wound therapy (MWT) in the treatment of diabetic foot ulcer patients.

Methods: This study enrolled 342 patients from 37 centers. Inclusion criteria were diabetic patients with adequate nutritional status, a foot ulcer 2 cm2 located on the dorsal, plantar or calcaneal region with adequate perfusion. Patients were randomized in a blinded fashion to either V.A.C. Therapy or MWT (eg, alginates, collagen, foam, hydrogels, hydrocolloids, gauze, etc.). Ulcers were treated until healed or Day 112 and patients were followed 38 weeks post closure. An interim intent-to-treat analysis was conducted after the enrollment of 275 patients.

Results: The interim analysis included 256 patients. The median time to ulcer closure with V.A.C. Therapy was 107 days and was not reached for MWT (P = 0.03). The median time for 76-100% granulation tissue formation, from 0-10%, was 56 days for V.A.C. Therapy and 114 days for MWT (P = 0.009). Final data from the acute treatment phase will be incorporated and updated results depicted.

Conclusion: V.A.C. Therapy was associated with a significant difference in granulation tissue formation and wound closure attainment. The interim analysis is promising and suggests that diabetic ulcer patients experience improved wound healing outcomes when treated with V.A.C. Therapy.

*V.A.C.® Therapy, KCI USA, San Antonio, Tex