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Intensive Glycemic Control For Diabetic Foot Ulcer Healing

NCT04323462 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2021-11-02

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Insulin Glargine

Three times bolus insulin with regular or Shorter acting insulin

DRUG

Diabetic DM

Previously receiving OADs and/or basal insulin

Sponsors & Collaborators

  • Institute of Post-Graduate Medical Education and Research, Kolkata

    collaborator OTHER

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences, Bhubaneswar

    collaborator OTHER

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323462 on ClinicalTrials.gov