The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudi… (NCT04800692) | Clinical Trial Compass
Active — Not RecruitingPhase 1
The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication
United States10 participantsStarted 2021-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 In…