RecruitingPhase 1NCT04800692

The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

The Effects of ATLAS (Arginine Tetrahydrobiopterin L-Ascorbate) Therapy on Nitric Oxide Bioavailability and Pain-free Walking in Patients With Intermittent Claudication


Sponsor

Louis Messina

Enrollment

10 participants

Start Date

Jun 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physical activity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a therapy called ATLAS (Augmentation of Limb Arterial Supply) can improve the availability of nitric oxide in patients with intermittent claudication — a painful cramping in the legs that occurs during walking due to reduced blood flow from peripheral artery disease (PAD). Nitric oxide helps blood vessels relax and widen, and improving its levels may relieve leg pain and improve walking ability. Participants have PAD diagnosed by ankle-brachial index (ABI) measurements and fall into Rutherford Classification II or III, meaning they have pain during walking but no critical limb ischemia. The study involves receiving ATLAS therapy over several sessions and measuring walking distances and blood markers. You may be eligible if: - You are 18 years or older - You have been diagnosed with PAD (confirmed by ABI less than 0.9 or TBI less than 0.7) - You fall into Rutherford Classification II or III (claudication without rest pain) - You are willing to stop certain medications like PDE5 inhibitors (e.g., Viagra, Cialis) and PDE3 inhibitors during the study You may NOT be eligible if: - You have critical limb ischemia (Rutherford Class IV, V, or VI) - You have had vascular surgery or endovascular intervention recently - Your walking is limited by reasons other than claudication (arthritis, lung disease, etc.) - You have had a heart attack, stroke, or deep vein thrombosis in the past 12 months - You are pregnant or planning to become pregnant - You have a history of seizures or nephrolithiasis (kidney stones) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTetrahydrobiopterin 10 mg/kg

10mg/kg of Tetrahydrobiopterin daily.

DRUGTetrahydrobiopterin 20 mg/kg

20mg/kg of Tetrahydrobiopterin daily.

DRUGL-Ascorbate

3300 mg of l-ascorbate once daily

DRUGL-Arginine

3400mg of l-arginine once daily


Locations(1)

UMASS Memorial Healthcare - University Campus

Worcester, Massachusetts, United States

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NCT04800692


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