The Effect of Individualised Glycemic Intervention on Wound Healing Rate in Diabetic Foot Ulcer (The EIGIFU Study)

OBJECTIVE: To evaluate the association of glycated haemoglobin (HbA(1c)) reduction and wound healing in patients with diabetic foot ulcer (DFU). METHODOLOGY: A 12-week prospective, non-controlled, interventional study in suboptimal-controlled T2DM patients with DFU was conducted. Antidiabetic medications were adjusted with the aim of at least 1% in relation to patient’s individualised HbA(1c) target. The wound area was determined by using specific wound tracing. The daily wound area healing rate in cm(2) per day was calculated as the difference between wound area at first visit and the subsequent visit divided by the number of days between the two visits. RESULTS: 19 patients were included in the study. There was a significant HbA(1c) reduction from 10.33 %+1.83% to 6.89%+1.4% (p<0.001) with no severe hypoglycaemia. The median daily wound area healing rate was 0.234 (0.025,0.453) cm(2)/day. There was a strong positive correlation between these two variables (r=0.752, p=0.01). After dividing the patients into four quartiles based on final HbA(1c) and comparing the first quartile vs fourth quartile, there was a significant difference in daily wound area healing rates (0.597 vs 0.044 cm(2)/day, p=0.012). CONCLUSION: There was a positive correlation between HbA(1c) reduction and wound healing rate in patients with DFU. Although this is an association study, the study postulated the benefits of achieving lower HbA1c on wound healing rate in DFU which require evidence from future randomised controlled studies.