Clinical Study of Methylene Blue - Mediated Photodynamic Therapy for Diabetic Lower Limb Ulcer

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

It had two arms (groups): Photodynamic Therapy (experimental) and Photon therapy (active comparator).

The photosensitizer, methylene blue, is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photodynamic therapy is applied once a day for a total of seven times.

The placebo is applied topically to the ulcer surface and the ulcer was shielded from light for 15 min. Then the ulcer area is illuminated using a photon therapy instrument for 20 minutes. Photon therapy is applied once a day for a total of seven times.

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: 1\. Understand the whole test process, voluntary and signed informed consent form. 2\. Men and women aged 18 to 80 years old. 3\. Diagnosed with diabetic lower limb ulcer. 4\. Ulcer duration\> 1 month of wagner grade Ⅱ, Ⅲ subjects. 5\. An ulcer area ≤100 cm² or of linear dimension ≤ 10 cm.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: 1\. diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent; 2\. pregnant or lactating women; 3\. wagner grade ⅰ, ⅳ, ⅴ subjects.

How the Study Was Run

Design: randomized, parallel-group 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.

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

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: care provider and outcomes assessor.

It started in 2019-04-29 with completion listed for 2020-04-29.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline （Ulcer area）in the diabetic lower limb ulcer at day 7 (time frame: Baseline and day 7). Change from baseline (immediately before the first treatment) in the bacterial load of the ulcer at one hour (immediately after the first treatment) (time frame: Baseline and (immediately after the first treatment)，day 7,14,21,28). Change from baseline(bacterial biofilm） (time frame: Baseline and day 7,14,21,28).

It also tracked 5 secondary outcomes, for example The time of antibiotics, Adverse events, A comparison of local NET neutrophil extracellular traps before the first treatment and after the tenth treatment and Inflammation control rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 60 people.

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.