Intensive Glycemic Control For Diabetic Foot Ulcer Healing

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had two arms (groups): Intensive Glucose Control (experimental) and Conventional Glucose control (active comparator).

The registry classes the interventions as drug.

More on the Plan

Multiple risk factors have been attributed to the development of DFU including male gender, duration of diabetes \>10 years, older age, diminished vision, peripheral vascular disease, high BMI, sensory neuropathy, retinopathy, nephropathy, HbA1c, foot deformity, high plantar pressures, poor foot care habits, barefoot walking etc.

IMPAIRED WOUND HEALING IN DIABETES Wound healing is impaired in diabetes at multiple stages.

The defects are observed at both cellular and molecular levels.

Who Took Part

Enrollment: 326 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \>18 years. Patients of DM according to ADA guidelines. DFU: Wagner grade 1, 2 \& 3 or UTS 1, 2-3B. Duration of ulcer\>2 weeks. Wound size: \>1cm2.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: diagnosis with unpredictable healing ability e.g. malignancy, depression, hiv, ctd, steroid use; anemia with hemoglobin \<10 gm/dl; active charcot foot.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2021-10-01 with completion listed for 2022-11.

It ran at 2 sites in India (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Wound Healing (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example wound area and time to ulcer healing.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 326 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.