Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes.

Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low.

It had two arms (groups): Intensive (active comparator) and Conventional (no intervention).

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

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

The registry classes the interventions as drug.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 19 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 2 \& 3 or UTS 2-3B. Duration of ulcer \<12 weeks. Wound size: \>1cm2.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: diagnosis with unpredictable healing ability e.g. malignancy, depression, hiv, ctd, steroid use; active charcot foot; PEDIS 4: life threatening DFU.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2017-11-01 with completion listed for 2019-06-30.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of participants with complete wound closure (epithelialisation) at 12 weeks in both intensive and conventional treatment groups (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example HbA1c at 4 & 12 weeks in both intensive and conventional groups, Change in ulcer severity- Wagner and UTWSC classification and Incidence of any amputation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 50 people.

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

More context: the Insulin (regular human) compound page, all human trials.