Intensive Glycemic Control For Diabetic Foot Ulcer Healing

NCT04323462 | Unknown Phase 4

• 1 other identifier: 100/20
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 2

Brief Summary

With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates. A study showed improvement in phagocytic activity of macrophages after 5 days of intensive glycemic improvement in 21 patients of diabetes. Another retrospective cohort study studied the effect on HbA1c as predictor of healing rate in DFU. Latter found significant association of HbA1c with wound area healing rate. However a recent systematic review failed to find any randomized control trial comparing the effect of intensive versus conventional glycemic control for treating DFU. Hence, investigators want to explore the hypothesis by conducting a randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer in response to intensive glycemic control in comparison to conventional glycemic management.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; Intensive Glycemic Control; Diabetic Foot Ulcer; Wound Healing; HbA1c

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Number of wounds that have closed Completely in the two arms. Complete closure of wound will be defined as epithelial action of ulcer

  12 weeks

Secondary Outcomes (2)

• wound area

  4 and 12 weeks

• time to ulcer healing

  upto 12 weeks

Other Outcomes (1)

• amputation

  12 weeks

Study Arms (2)

Intensive Glucose Control

EXPERIMENTAL

Intensive Glucose control Insulin ≥3 times per day; Goals: prePBG 80-130 \& post PBG \<180 (60% of all readings); HbA1c \<8% at 3 months SMBG at least 14 readings/week (3-5 FBG, rest PPBG) and/or CGMS readings Reexamined weekly for 1 month; then fortnightly for 3 months and then monthly till 6 months Intensive subgroup will receive a standard glucometer with strips as one-week supply or CGMS for glycemic monitoring. They will receive a diabetic monitoring log/chart for home use. The chart and glucometer will have to be shown at each week of follow up. Number of hypoglycemic events in past week will be checked for each patient. This sub group will receive instructions to use 3 times bolus (regular/analogue) and single time basal insulin (glargine). Treatment goals will be conveyed at first contact and reinforced at each visit. Insulin dose modulation will be done telephonically. Patients will be reviewed weekly for 1 month and then fortnightly.

Drug: Insulin Glargine

Conventional Glucose control

ACTIVE COMPARATOR

Fixed dosage of oral anti-diabetic drugs/insulin per week as patient is receiving prior; Insulin \<3 times per day SMBG \<3 times per day

Drug: Diabetic DM

Interventions

Insulin Glargine DRUG

Three times bolus insulin with regular or Shorter acting insulin

Also known as: Bolus Insulin

Intensive Glucose Control

Diabetic DM DRUG

Previously receiving OADs and/or basal insulin

Also known as: OADs

Conventional Glucose control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients of DM according to ADA guidelines
• HbA1c \>8% (single occasion at screening) and/or FBG \>130 on 3 consecutive occasions
• DFU: Wagner grade 1, 2 \& 3 or UTS 1, 2-3B
• Duration of ulcer\>2 weeks
• Wound size: \>1cm2
• Willingness to sign consent form \& participate in the study
• Capacity to attend visits at hospital for review

You may not qualify if:

• Diagnosis with unpredictable healing ability e.g. malignancy, depression, HIV, CTD, steroid use
• Dialysis requiring CKD \& eGFR \<30 ml/min
• Anemia with hemoglobin \<10 gm/dl
• Active Charcot foot
• PEDIS 4: life threatening DFU
• Pregnancy
• ABI \<0.7
• Refusal to give informed consent

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Institute of Post-Graduate Medical Education and Research, Kolkata: collaborator
• Jawaharlal Institute of Postgraduate Medical Education & Research: collaborator
• All India Institute of Medical Sciences, Bhubaneswar: collaborator

Study Sites (2)

IPGMER

Kolkata, West Bengal, 189212, India

RECRUITING

Deptt of Endocrinology

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ashu Rastogi, MD, DM

CONTACT

919781001046; ashuendo@gmail.com

ashu Rastogi, DM

CONTACT

9781001046; ashuendo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and the Outcome assessor will not be aware of group allocation and the treatment thus offered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)