Effects of Local Insulin on Varicose Ulcers for Wound Healing

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

A randomized, split-plot, double-blind, placebo-controlled trial.

The varicose ulcer is divided into two (side A and B).

Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm.

It had two arms (groups): Topical insulin glargine (experimental) and one (placebo comparator).

The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized.

The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized.

The registry classes the interventions as drug.

More on the Plan

Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study.

A split-mouth model is used.

The ulcer is divided into two (sides A and B).

The side in which treatment is applied is randomized.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Presence of varicose ulcer in lower extremities with a size greater than 25 cm2. Absence of infection.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: comorbidities that affect wound healing; active smoking.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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: participant and investigator.

It started in 2019-06-01 with completion listed for 2019-12-31.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Final angiogenesis (time frame: Day 7).

It also tracked 3 secondary outcomes, for example Fibroplasia, Thermal asymmetry and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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