Effects of Local Insulin on Wound Angiogenesis

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

Randomized, split plot, double-blind, placebo controlled trial.

Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo.

Biopsy specimens of the two sides were obtained on days 0 and 14.

It had two arms (groups): Insulin (experimental) and Placebo (placebo comparator).

Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized.

Half of the wound surface was treated daily with normal saline. Allocation was randomized.

The registry classes the interventions as drug.

More on the Plan

Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo.

Biopsy specimens of both sides will be obtained on days 0 and 14.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Nondiabetic patients with full-thickness acute wounds.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: diabetic patients.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2014-10 with completion listed for 2015-04.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of blood vessels (time frame: 14 days).

It also tracked 1 secondary outcome, for example Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 20 people.

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

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.