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Topical Insulin for Postoperative Wound Healing

Plain-language guide to NCT06400082: not phased randomized trial of Insulin (regular human), insulin resistance, prediabetes & type 2 diabetes, 74 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06400082
Phase
not phased
Status
status unknown
Start
2023-04-16
Completion (planned or actual)
2024-10-01
Participants
74 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Wound Complication; Insulin Resistance, Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes.

The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress.

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

The registry classes the interventions as drug.

Who Took Part

74 actual participants took part.

It was open to people of any sex aged from 40 years up to 60 years.

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

Examples of who could join: Both males and females. 40-60 years old. Diagnosed with type 2 DM (for the diabetic trial). Patients who had a full thickness post-operative wound of ≥10 cm.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion; patients who had hypersensitivity to insulin,; patients with severe infection,.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind 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.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-04-16 with completion listed for 2024-10-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Calculation of Unit Healing Time index (time frame: Before and after 7 days of therapy).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 74 people with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.