Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Age >18 years

2. Patients of DM according to ADA guidelines

3. HbA1c >8% and/or FBG >130 on 3 consecutive occasions

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

5. Duration of ulcer <12 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. Active Charcot foot

4. PEDIS 4: life threatening DFU

5. Pregnancy

6. ABI <= 0.7

7. Refusal to give informed consent