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

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ClinicalTrials.gov Identifier: NCT03740581
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ashu Rastogi, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Insulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing: a Randomised Control Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups. [ Time Frame: 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 :
  1. Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups. [ Time Frame: 4 and 12 weeks ]
    This will be calculated using the measured ulcer area for all participants, irrespective of wound closure status.

  2. HbA1c at 4 & 12 weeks in both intensive and conventional groups. [ Time Frame: 4 and 12 weeks ]
    This ill be done to correlate glycemic control with ulcer area at 4 and 12 weeks respectively.

  3. Change in ulcer severity- Wagner and UTWSC classification. [ Time Frame: 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.

  4. Incidence of any amputation. [ Time Frame: 4 and 12 weeks ]
    This outcome to be correlated with the glycemic control in both the groups.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740581


Contacts
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Contact: Aditya Dutta, MD +919818892996 addiedutta05@gmail.com
Contact: Ashu Rastogi, MD, DM +919781001046 ashuendo@gmail.com

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

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Responsible Party: Ashu Rastogi, Assistant Professor, Department of Endocrinology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03740581     History of Changes
Other Study ID Numbers: PGIMER ENDO
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Ashu Rastogi, Postgraduate Institute of Medical Education and Research:
Diabetic foot ulcer
Intensive glycemic control

Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs