drugset / Trial / NCT03740581

Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

NCT03740581

RandomizedParallel-groupOpen-labelTreatment

Summary

Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.

Timeline

Start
2017-11-01
Primary completion
2019-06-30
Completion
2019-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic

Indications