Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: Insulin

• Registration Number: NCT03740581
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-10
• Last Update Submitted: 2018-11-10
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive	Insulin	New anti-diabetic drug regimen with (mandatory) Insulin \>= 3 times per day

Primary Outcome Measures

Name	Time	Method
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.	4 and 12 weeks	This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.
Change in ulcer severity- Wagner and UTWSC classification.	4 and 12 weeks	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.
HbA1c at 4 & 12 weeks in both intensive and conventional groups.	4 and 12 weeks	This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.
Incidence of any amputation.	4 and 12 weeks	This outcome to be correlated with the glycemic control in both the groups.

Trial Locations

Locations (1)

Postgraduate Medical Institute of Medical Education and Research; 🇮🇳 Chandigarh, India