NCT03740581

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

November 5, 2018

Last Update Submit

November 10, 2018

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic foot ulcerIntensive glycemic control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Percent reduction in ulcer area (from baseline) at 4 & 12 weeks in both intensive and conventional treatment groups.

    4 and 12 weeks

  • HbA1c at 4 & 12 weeks in both intensive and conventional groups.

    4 and 12 weeks

  • Change in ulcer severity- Wagner and UTWSC classification.

    4 and 12 weeks

  • Incidence of any amputation.

    4 and 12 weeks

Study Arms (2)

Intensive

ACTIVE COMPARATOR

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

Drug: Insulin

Conventional

NO INTERVENTION

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

Interventions

InsulinDRUG

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

Intensive

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • Active Charcot foot
  • PEDIS 4: life threatening DFU
  • Pregnancy
  • ABI \<= 0.7
  • Refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Medical Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Aditya Dutta, MD

CONTACT

+919818892996addiedutta05@gmail.com

Ashu Rastogi, MD, DM

CONTACT

+919781001046ashuendo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Endocrinology

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 14, 2018

Study Start

November 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)