Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

Diabetic Foot Ulcer Clinical Trial

— InVeCoG:DFU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740581
• Other study ID #: PGIMER ENDO
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2018
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Aditya Dutta, MD
• Phone: +919818892996
• Email: addiedutta05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Insulin
Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)

Locations

Country	Name	City	State
India	Postgraduate Medical Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Incidence of any amputation.	This outcome to be correlated with the glycemic control in both the groups.	4 and 12 weeks