Carnosine for Peripheral Vascular Disease

What Was Tested

The trial (phase 2) is built around Carnosine.

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

The registry classes the interventions as drug.

More on the Plan

Although surgical or endovascular revascularisation are available treatments, not all patients are suitable for the procedure, and grafts can fail, and dilated arteries can restenose.

Angiogenesis plays an essential role for recovery from critical limb ischaemia.

Hypoxia inducible factor 1α (HIF1-α), a master regulator of angiogenic genes, has been implicated .

Under normal conditions, HIF1-α is targeted for proteasomal degradation through the activity of prolyl hydroxylases (PHDs).

Who Took Part

The registry lists 104 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: Age \>=40or \<80 years. Clinical diagnosis Peripheral Vascular disease. Rutherford Grade 1-3. Intermittent claudication on treadmill between 30m and 200m. Ankle Brachial index 0.6-1 at rest with minimum post exercise drop in ABI of 0.1.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: age \< 40 or \> 80 years; pregnant or lactating; limb threatening ischaemia- rutherford grades 4-6, manifested by ischaemic rest pain, ulceration, or gangrene; acute limb-threatening ischaemia.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Carnosine and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Carnosine.

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

It started in 2019-03-01 with completion listed for 2022-12-31.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: walking endurance (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Carnosine in 104 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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