The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

What Was Tested

In this early phase 1 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had four arms (groups): Methylene Blue (experimental), Milk (control) (experimental), Methylene Blue and Platelet-Rich Plasma-Fibrin Glue (experimental) and Milk and Platelet-Rich Plasma-Fibrin Glue (control) (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing DFU).

This randomized controlled trial is performed on 20 patients with non-healing DFU.

Who Took Part

20 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Having a Diabetic ulcer grade II and IV based on Wagner's classification on the sole, medial, or lateral part of the foot (including all surfaces of the toes). If there is more than one non-healing wound, choose the largest wound. The size of the wound surface (length × width) between 2 cm2 and 20 cm2. No smoking, alcohol, and drug addiction based on the patient's self-report. Not taking drugs that may interfere with wound healing, such as Corticosteroids, immunosuppressants, and cytotoxic agents.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: do not be treated with methylene blue; the confirmed presence of osteomyelitis, or if there is suspicion of osteomyelitis; the subject is pregnant or intends to become pregnant during the test period.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-04-30 with completion listed for 2023-08-21.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The healing rate of the ulcer (time frame: 4 weeks). Wound Size (time frame: 4 weeks).

It also tracked 33 secondary outcomes, for example TcPO2 at baseline and after the intervention, Oxygen saturation at baseline and after the intervention, Blood pressure (systolic and diastolic), The resting systolic toe pressure (TP) at baseline and after the intervention, Serum IL-1β levels at baseline and after the intervention and Serum MCP-1 levels at baseline and after the intervention.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Methylene blue (non-peptide stack partner) 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 Methylene blue (non-peptide stack partner) compound page, all human trials.