RECRUITING

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

Conditions

Claudication, Intermittent Peripheral Artery Disease Peripheral Vascular Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-15

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04800692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Shauneen Valliere, MSN

CONTACT

508-856-1767

shauneen.valliere@umassmed.edu

Mollynda McArthur, MS

CONTACT

508-856-2820

mollynda.mcarthur2@umassmed.edu

Principal Investigator

Louis M Messina, MD

PRINCIPAL_INVESTIGATOR

UMASS Medical School

Study Locations (Sites)

UMASS Memorial Healthcare - University Campus

Worcester, Massachusetts, 01655

United States

Collaborators and Investigators

Sponsor: Louis Messina

Louis M Messina, MD, PRINCIPAL_INVESTIGATOR, UMASS Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-15

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-06-15

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Claudication, Intermittent
Peripheral Artery Disease
Peripheral Vascular Diseases