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Medicine: Evidence-Based Research: Plenary Session
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Moderator: George T. Rodeheaver, PhD Abstract This session will present new evidence-based data from recently performed clinical trails to be chosen before the meeting. Dr. Rodeheaver will moderate the session and provide introductions where appropriate. (Presentation 23.5) A pilot clinical study for the treatment of diabetic foot ulcers with an injectable bioactive co-polymer JR Hanft, DPM, Foot & Ankle Institute of South Florida, South Miami, Fla; PA Blume, North American Foundation for Limb Preservation, New Haven, Conn; P Dardik, Englewood Hospital & Medical Center, Englewood, NJ; I Gordon, VA Long Beach Healthcare System, Long Beach, Calif; RS Hill, Encelle, Inc., Greenville, NC; AI Landsman, Weil Foot & Ankle Institute, Des Plains, Ill; S Lipkin, Allentown Medical Center, Allentown, Pa; WA Marston, UNC Wound Management Clinic, Durham, NC; J Morgan; D Orgill, MD, Brigham & Women’s Hospital, Boston, Mass; A Tallis, Research Institute, Phoenix, Ariz Abstract: In a randomized, controlled, pilot clinical trial, a novel co-polymer (porcine gelatin, dextran, and stabilizers) was used to treat diabetic foot ulcers. Safety, the primary endpoint, was measured by adverse event reporting and clinical laboratory analysis. Wound closure, the secondary endpoint, was based on intent to treat. Fifty-six patients were prospectively randomized at 10 centers (25 control; 31 co-polymer). All patients received sharp debridement, CAM walker offloading, and hydrogel dressings daily. Co-polymer was injected subcutaneously under treated wounds. Patients were monitored for 12 weeks by clinical examination and wound planimetry/photography. There was no significant difference in adverse event reporting between groups. Co-polymer wound closure rate was 42% (13/31) versus 32% (8/25) for controls. Co-polymer appeared to be more effective than control for larger (>2 cm2: 8/17, 47%, versus 4/14, 29%) and older (>17 weeks duration: 6/15, 40%, versus 3/15, 20%) wounds. In conclusion, co-polymer and control treatment demonstrated a similar safety profile, and there was a trend toward improved healing in larger and older high-risk wounds. Further trials are necessary to confirm these promising initial results. |
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