Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing (InVeCoG:DFU)

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Insulin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aditya Dutta, MD; Phone Number: +919818892996; Email: addiedutta05@gmail.com
• Study Contact Backup: Name: Ashu Rastogi, MD, DM; Phone Number: +919781001046; Email: ashuendo@gmail.com

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Postgraduate Medical Institute of Medical Education and Research
    • Contact: Aditya Dutta, MD; Phone Number: +919818892996; Email: addiedutta05@gmail.com
    • Contact: Ashu Rastogi, MD, DM; Phone Number: +919781001046; Email: ashuendo@gmail.com
    • Sub-Investigator: Anil Bhansali, MD, DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 10, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 10, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Intensive glycemic control
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: PGIMER ENDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No