drugset
drugset / Trial / NCT04323462

Intensive Glycemic Control For Diabetic Foot Ulcer Healing

NCT04323462 ↗

Phase 4 Unknown 326 enrolled Post Graduate Institute of Medical Education and Research, Chandigarh All India Institute of Medical Sciences, Bhubaneswar · collabInstitute of Post-Graduate Medical Education and Research, Kolkata · collabJawaharlal Institute of Postgraduate Medical Education & Research · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates. A study showed improvement in phagocytic activity of macrophages after 5 days of intensive glycemic improvement in 21 patients of diabetes. Another retrospective cohort study studied the effect on HbA1c as predictor of healing rate in DFU. Latter found significant association of HbA1c with wound area healing rate. However a recent systematic review failed to find any randomized control trial comparing the effect of intensive versus conventional glycemic control for treating DFU. Hence, investigators want to explore the hypothesis by conducting a randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer in response to intensive glycemic control in comparison to conventional glycemic management.

Timeline

Start
2021-10-01
Primary completion
2022-11
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — —

Indications

ulcer of lower limbs