Topical Insulin Dressing on Management of Diabetic Foot Ulcers

What Was Tested

This registered not phased trial tested Insulin (regular human).

This study aimed to find out the advantages of topical insulin in the management of diabetic foot ulcers over the conventional wound saline dressing.

It had two arms (groups): Group A (soluble insulin (Actrapid)) (experimental) and Group B (normal saline) (active comparator).

The ulcers were cleaned with normal saline without insulin and covered with sterile cotton gauzes.

The registry classes the interventions as drug.

More on the Plan

Non healing foot ulcers constitute a major problem that plagues those with diabetes due to angiopathy and neuropathy.

It is well known that the basic cellular and molecular mechanisms that result in wound healing involve cell adhesion, migration, proliferation, differentiation, and apoptosis.

Insulin stimulates the growth and development of different cell types and affects proliferation, migration, and secretion by keratinocytes, endothelial cells, and fibroblasts.

Who Took Part

The registry lists 30 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: Patients with diabetes between the age group 18-85 years. Patients having ulcer below the ankle on the dorsal or plantar aspect of the foot. Patients with controlled blood glucose levels between 110 and 130 gm/dl. Hemoglobin A1c was 7.1 ± 0.34.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: patients with diabetic foot ulcers of wagner grade v; X-ray showing features of osteomyelitis; malnutrition and uncontrolled diabetes mellitus.

How the Study Was Run

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

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

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-01-01 with completion listed for 2024-01-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of diabetic foot ulcer healing (time frame: 12 weeks after the treatment).

It also tracked 1 secondary outcome, for example Need for surgical debridement.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 30 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 (regular human) compound page, all human trials.