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
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.
Address correspondence and reprint requests to Aristidis Veves, MD, Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd., Boston, MA 02215. E-mail:.
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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