Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Patients of DM according to ADA guidelines HbA1c >8% and/or FBG >130 on 3 consecutive occasions DFU: Wagner grade 2 & 3 or UTS 2-3B Duration of ulcer <12 weeks Wound size: >1cm2 Willingness to sign consent form & participate in the study Capacity to attend visits at hospital for review Exclusion Criteria: Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use Dialysis requiring CKD & eGFR <30 ml/min Active Charcot foot PEDIS 4: life threatening DFU Pregnancy ABI <= 0.7 Refusal to give informed consent

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive<br>New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day | Drug: Insulin<br>* Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)<br>|
| No Intervention: Conventional<br>Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups. | Ulcer area to be measured by Wound Measurement Camera model WZ2.0 (bought from (Wound zoom incorporate, 2916, Borham Ave, Stevens Point, W1, USA 54481) at baseline, 4 and 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups. | This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status. | 4 and 12 weeks | 
| HbA1c at 4 & 12 weeks in both intensive and conventional groups. | This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively. | 4 and 12 weeks | 
| Change in ulcer severity- Wagner and UTWSC classification. | Downgrade of ulcer severity based on two well established diabetic foot ulcer classification systems and there correlation with wound closure and glycemic control will be seen. | 4 and 12 weeks | 
| Incidence of any amputation. | This outcome to be correlated with the glycemic control in both the groups. | 4 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot ulcer, Intensive glycemic control