Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive

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

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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

Conventional

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No