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

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Trial Status Recruiting

Trial Identifier

NCT04800692

Condition

Claudication, Intermittent, Peripheral Artery Disease, Peripheral Vascular Diseases

Study Resources

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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 Criteria

Birth Sex

All

Age

From 18 Years

Healthy Volunteers

No

Drug/Treatment:

Tetrahydrobiopterin 10 mg/kg, Tetrahydrobiopterin 20 mg/kg, L-Ascorbate, L-Arginine

Phase:

Phase 1

Study Type:

Interventional

Number of Participants:

10

Study Started:

2021-06-15

Study Updated:

2025-04-06

Trial Locations

  • UMASS Memorial Healthcare - University Campus

    Worcester, Massachusetts, United States

Inclusion Criteria

  • PAD as demonstrated by an ABI <0 .9 in one leg or TBI less than 1.3 (non compressible vessels)
  • Rutherford Classification II, III
  • Age >18 years old
  • Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio
  • Willingness to discontinue phosphodiesterase (PDE) 3inhibitors cilostazol, milrinone or Vesnarinone
  • Willing and able to comply with all study procedures
  • Willing and able to provide informed consent
  • Sexually active subjects willing to use an acceptable method of contraception while participating in the study

Exclusion Criteria

  • Hypotension defined as a systolic blood pressure less than 100mmhg systolic at screening or baseline visit
  • Critical Leg Ischemia (Rutherford Classification IV, V, VI)
  • Surgical intervention to alleviate symptoms of claudication in the study leg within the past 6 months or any endovascular interventions within 3 months or who is scheduled to undergo surgical revascularization in the next 6 month
  • Walking limited by reasons other than claudication (e.g. arthritis, lung disease, severe neuropathy, lower extremity amputation except single digits)
  • Serum creatinine >1.5mg/dl or Hepatic enzymes >2X the upper limit of normal
  • Serum potassium greater than 5.0 or use of a potassium sparing diuretic at screening
  • Pregnant, breast feeding or planning to become pregnant (subject or partner) at any time during the study.
  • Myocardial Infarction, Cerebrovascular Accident or deep vein thrombosis within 12 months of screening
  • Known history of nephrolithiasis
  • History of ever having a seizure
  • Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, organ transplant, long term immunosuppression (excluding inhaled steroids), current neoplasm or severe gastroesophageal reflux
  • History of vertigo or syncope within the past 10 years
  • Enrollment in another drug or device study within 30 days of screening
  • Required treatment with a drug known to inhibit folate metabolism (e.g. Methotrexate)
  • Taking any of the following medications; PDE3 Inhibitors, PDE5 inhibitors, trental, nitrates, ginkgo biloba, levodopa, warfarin,
  • Axillary lymph node dissection
  • Presence of an amputation except single digits in either leg
  • Preexisting illness that limits ambulation such as severe COPD, class III-IV heart failure, severe arthritis or back pain
  • Glucose-6-dehydrogenase deficienc

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