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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Massachusetts, Worcester
• Collaborator: National Institute on Aging (NIA)
• Treatments: Verapamil

Criteria

Inclusion Criteria:

• 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

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 deficiency