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

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Insulin
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic foot ulcer, Intensive glycemic control

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Medical Institute of Medical Education and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intensive

Conventional

Arm Description

New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day

Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Incidence of any amputation.
This outcome to be correlated with the glycemic control in both the groups.

Full Information

First Posted
November 5, 2018
Last Updated
November 10, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03740581
Brief Title
Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing
Acronym
InVeCoG:DFU
Official Title
The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic foot ulcer, Intensive glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive
Arm Type
Active Comparator
Arm Description
New anti-diabetic drug regimen with (mandatory) Insulin >= 3 times per day
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Old anti-diabetic drug regimen with or without Insulin (<3 times per day) to be continued as before
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)
Primary Outcome Measure Information:
Title
Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.
Description
This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.
Time Frame
4 and 12 weeks
Title
HbA1c at 4 & 12 weeks in both intensive and conventional groups.
Description
This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.
Time Frame
4 and 12 weeks
Title
Change in ulcer severity- Wagner and UTWSC classification.
Description
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.
Time Frame
4 and 12 weeks
Title
Incidence of any amputation.
Description
This outcome to be correlated with the glycemic control in both the groups.
Time Frame
4 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aditya Dutta, MD
Phone
+919818892996
Email
addiedutta05@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashu Rastogi, MD, DM
Phone
+919781001046
Email
ashuendo@gmail.com
Facility Information:
Facility Name
Postgraduate Medical Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditya Dutta, MD
Phone
+919818892996
Email
addiedutta05@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashu Rastogi, MD, DM
Phone
+919781001046
Email
ashuendo@gmail.com
First Name & Middle Initial & Last Name & Degree
Anil Bhansali, MD, DM

12. IPD Sharing Statement

Plan to Share IPD
No

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Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

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