Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

What Was Tested

This registered phase 1, phase 2 trial tested Carnosine.

It had two arms (groups): Placebo (no intervention) and Carnosine (experimental).

Cellulose.

The registry classes the interventions as drug.

More on the Plan

In this pilot study the researchers will enroll 144 participants that will be divided into placebo (n=72) and carnosine groups (n=72).

The researchers will measure the distance covered on the 6-minute walk test (6-MWT) and the pain free walking capacity on the treadmill before and after the placebo or carnosine supplementation.

Following completion of the study, the researchers will follow the participants for another 3 months and examine the durability of carnosine supplementation.

Who Took Part

The registry lists 144 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Participants between 40-80 years of age. White or African American race. Literate in English. ABI \>0.4-\<0.90, obtained within 6 weeks from enrollment. Willing and able to comply with protocol requirements.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg; participants with a baseline 6mwt of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft); known allergy to l-carnosine.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

The Carnosine group and the comparison group ran side by side rather than switching.

As a double-blind Carnosine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-05-20 with completion listed for 2028-10-01.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Measure distance covered on six-minute walk test (6MWT) (time frame: Baseline, 3 months, 6 months, 9 months).

It also tracked 19 secondary outcomes, for example Measure Ankle-Brachial Index (ABI), Treadmill Testing, Skin Integrity, Musculoskeletal Assessment, Neuromuscular Assessment and Balance Assessment.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Carnosine in 144 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.