The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
Running, not enrolling · Phase 1
Conditions studied: Claudication, Intermittent, Peripheral Artery Disease, Peripheral Vascular Diseases
In brief
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.
Key facts
- Study ID
- NCT04800692
- Run by
- Louis Messina
- People needed
- 10
- Starts
- 2021-06-15
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- PAD as demonstrated by an ABI <0 .9 in one leg or TBI less than <0.7 in patients with an ABI >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
You may not qualify if…
- 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 deficiency
Where it is running
- UMASS Memorial Healthcare - University Campus — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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