Overview

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