Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a simple supplement mix help leg pain sufferers walk pain-free?

NCT ID NCT04800692

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether a combination of arginine, tetrahydrobiopterin, and vitamin C can boost nitric oxide levels in the blood and help people with peripheral artery disease walk longer without pain. Ten participants will take the therapy and be monitored for changes in pain-free walking distance. The goal is to see if this approach can ease symptoms and improve daily activity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Claudication, intermittent are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UMASS Memorial Healthcare - University Campus

    Worcester, Massachusetts, 01655, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.