Intensive Glycemic Control For Diabetic Foot Ulcer Healing

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborators: All India Institute of Medical Sciences, Bhubaneswar; All India institute of medical sciences, Raipur; Amrita Institute of medical sciences and research Center kochi; Hinduja hospitals mumbai; Institute of Post-Graduate Medical Education and Research, Kolkata; Jawaharlal Institute of Postgraduate Medical Education & Research; Jawaharlal nehru institute of medical education and research Puducherry; Max super speciality hospitals New Delhi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Age >18 years

2. Patients of DM according to ADA guidelines

3. HbA1c >8% (single occasion at screening) and/or FBG >130 on 3 consecutive occasions

4. DFU: Wagner grade 1, 2 & 3 or UTS 1, 2-3B

5. Duration of ulcer>2 weeks

6. Wound size: >1cm2

7. Willingness to sign consent form & participate in the study

8. Capacity to attend visits at hospital for review

Exclusion Criteria:

1. Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use

2. Dialysis requiring CKD & eGFR <30 ml/min

3. Anemia with hemoglobin <10 gm/dl

4. Active Charcot foot

5. PEDIS 4: life threatening DFU

6. Pregnancy

7. ABI <0.7

8. Refusal to give informed consent