Early and Intensive Glycemic Control for Diabetic Foot Ulcer Healing: A Prospective Observational Nested Cohort Study.

Abstract

We aimed to assess the effect of glycemic control on diabetic foot ulcer (DFU) healing. A prospective nested cohort study was employed of individuals with poorly controlled diabetes (glycated hemoglobin [HbA1c] >9%) and neuropathic DFU of >2-week duration. All individuals received standard diabetes and ulcer interventions for 12 weeks. Baseline demographic characteristics, ulcer area (automated assessment by wound zoom camera), and biochemical parameters were analyzed. The cohort was stratified into ulcer healed and unhealed groups. Ulcer area and glycemic parameters at 4 and 12 weeks on follow up were compared. Forty-three individuals (47 DFU) with baseline HbA1c 11.6% and ulcer area 9.87 cm2 were enrolled. After 12 weeks, mean HbA1c was 7.2%, 17 ulcers closed (healed group) and 30 ulcers did not close (unhealed group). The median time to ulcer healing was 10 weeks. Individuals in the healed group had lower fasting blood glucose (P = .010), postprandial blood glucose (P = .006), and HbA1c at 4 weeks (P = .001), and 12 weeks (0.018) compared to the unhealed group. Cox-regression analysis that revealed lower baseline ulcer area (P = .013) and HbA1c at 4 weeks (P = .009) significantly predicted DFU healing by 12 weeks. Baseline ulcer area of >10.58 cm2 and HbA1c at 4 weeks of >8.15% predicted delayed DFU healing. In conclusion, early and intensive glycemic control in the first 4 weeks of treatment initiation is associated with greater healing of DFU independent of initial ulcer area.