4067.0: Tuesday, November 14, 2000 - 9:30 AM

Abstract #6704

Rate of healing of diabetic neuropathic foot ulcers treated with standard care and growth factor therapy: Implications for clinical practice and trial design

Jonathan Kantor, MA and David J. Margolis, MD, MSCE. School of Medicine, Department of Biostatistics and Epidemiology, University of Pennsylvania, Room 110 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104, 215-573-8908, jkantor@cceb.med.upenn.edu

Diabetic foot ulcers result in more than 85,000 lower extremity amputations each year. Most studies examining the efficacy of novel treatments for these ulcers have used a 20 week endpoint. Platelet Releasate (PR), autologous platelet-derived growth factor (PDGF) injected directly into the wound, is used in wound care centers operated by Curative Health Services (CHS). We examined the percentage of wounds healed between 4 and 52 weeks of care for wounds treated with standard care (SC) or PR. Our analysis is based on a validated database created by CHS that includes data on over 26,500 patients. Wounds treated with SC reached a healing plateau after approximately 20 weeks, but the percentage of healed wounds treated with PR continued to increase through 40 weeks of care. Moreover, the percentage healed after one year of therapy was 38.68% (95% confidence intervals (CI) [37.9%, 39.4%]) for SC and 54.62% (95% CI [53.2%, 56.0%]) for PR, representing a 41.2% relative improvement in percentage healed over SC. Using a cutoff of 20 weeks in studies examining the efficacy of growth factor therapy may be inappropriate, since the benefits of this therapy only become obvious after >20 weeks of care. Clinicians using PDGF therapy should appreciate that lengthy treatment may be necessary.

Learning Objectives: At the conclusion of the session, the participant in this session will be able to: 1. Evaluate a patient with a diabetic foot ulcer, understanding the expected rate of wound healing. 2. Recognize the limitations of the extant literature on the treatment of diabetic foot ulcers. 3. Apply the information presented to future care of patients with diabetic foot ulcers. 4. Apply data regarding healing trends to future clinical trials of therapy for these wounds

Keywords: Diabetes, Elderly

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Curative Health Services
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: CHS has provided a grant to the Trustees of the University of Pennsylvania

The 128th Annual Meeting of APHA