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Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Plain-language guide to NCT04390815: phase 4 randomized trial of Insulin (regular human), 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04390815
Phase
phase 4
Status
status unknown
Start
2020-08
Completion (planned or actual)
2020-12
Participants
30 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Wound Heal
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

It had two arms (groups): Intervention (experimental) and Control (placebo comparator).

Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin.

The registry classes the interventions as drug.

More on the Plan

This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics.

The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing.

Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adult patients with Texas 1 and 2 wound criteria.

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

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 2020-08 with completion listed for 2020-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area of wound healing (time frame: 4 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 30 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.

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.