Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial
- Peter Sheehan, MD1,
- Peter Jones, MSC2,
- Antonella Caselli, MD3,
- John M. Giurini, DPM3 and
- Aristidis Veves, MD3
- 1Diabetes Foot and Ankle Center, Hospital for Joint Diseases Orthopaedic Institute, New York University School of Medicine, New York, New York
- 2With Confidence Ltd., Surrey, U.K.
- 3Joslin-Beth Israel Deaconess Foot Center and Microcirculation Laboratory, Department of Surgery, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
Abstract
OBJECTIVE—To assess the ability of the 4-week healing rate to predict complete healing over a 12-week period in a large prospective multicenter trial of diabetic patients with foot ulceration.
RESEARCH DESIGN AND METHODS—We examined the change in ulcer area over a 4-week period as a predictor of wound healing within 12 weeks in patients who were seen weekly in a prospective, randomized controlled trial.
RESULTS—Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 vs. 0.8 cm2, P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70–94), whereas in those who failed to heal, the percent change in wound area was 25% (15–35; P < 0.001).
CONCLUSIONS—The percent change in foot ulcer area after 4 weeks of observation is a robust predictor of healing at 12 weeks. This simple tool may serve as a pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to standard care and may need additional treatment.
Footnotes
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Address correspondence and reprint requests to Aristidis Veves, MD, Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd., Boston, MA 02215. E-mail: aveves{at}caregroup.harvard.edu.
Received for publication 4 December 2002 and accepted in revised form 25 February 2003.
P.J. is a paid statistical consultant for Ethicon Ltd. P.S. and A.V. have been members of advisory panels for and have received honoraria and research grants from Johnson & Johnson Wound Management/Ethicon.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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