CLINICAL TRIAL

L-Ascorbate for Intermittent Claudication

Recruiting · 18+ · All Sexes · Worcester, MA

This study is evaluating whether a combination of therapies may help improve physical activity for individuals with peripheral arterial disease.

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About the trial for Intermittent Claudication

Eligible Conditions
Intermittent Claudication · Peripheral Arterial Disease · Peripheral Arterial Disease (PAD) · Peripheral Vascular Diseases · Vascular Diseases

Treatment Groups

This trial involves 2 different treatments. L-Ascorbate is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
L-Arginine
DRUG
+
Tetrahydrobiopterin 10 mg/kg
DRUG
+
L-Ascorbate
DRUG
Experimental Group 2
L-Arginine
DRUG
+
Tetrahydrobiopterin 20 mg/kg
DRUG
+
L-Ascorbate
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arginine
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who take cilostazol, milrinone or Vesnarinone are willing to discontinue their use of these drugs. show original
She is willing and able to comply with all study procedures. show original
is a predictor of major adverse limb and brain outcomes PAD, as demonstrated by an ABI less than 0.9 in one leg or TBI less than 0.7 in patients with an ABI greater than 1.3 (non compressible vessels), is a predictor of major adverse limb and brain outcomes. show original
The Rutherford classification is used to describe the type of nuclear reaction show original
You must be over 18 years old to rent a car. show original
, and Stendra before surgery It is possible that your surgeon will ask you to discontinue taking phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio, and Stendra before surgery. show original
The person needs to be willing and able to provide informed consent in order to participate in the study show original
will be recruited from the campus community People who are sexually active and willing to use contraception while participating in a study will be recruited from the campus community. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 90 days
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 90 days.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether L-Ascorbate will improve 1 primary outcome in patients with Intermittent Claudication. Measurement will happen over the course of 90 days.

Nitric Oxide bioavailability
90 DAYS
Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD).
90 DAYS

Who is running the study

Principal Investigator
D. J.
Prof. Douglas Jones, Assistant Professor
University of Massachusetts, Worcester

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get intermittent claudication a year in the United States?

In 1999/2000, about 6.3 million people experienced symptoms of intermittent claudication. On average, about 1750 new cases are diagnosed each year in this population. This survey provides a benchmark with respect to rates from past studies and emphasizes the need for more comprehensive research and for national surveillance in order to develop and evaluate treatment strategies.

Anonymous Patient Answer

What are the signs of intermittent claudication?

A person with a clinical diagnosis of claudication should receive appropriate workup with a vascular consultation. The following signs will most frequently trigger a vascular consultation:\n- Resting limb pain.\n- Pain with activity: walking or rising from a chair.\n- Symptoms such as erythema, ischemia, and/or swelling.\n- Muscle tenderness.\n- Dyspnea or fatigue and decreased lung volume.\n- Tachycardia.

Anonymous Patient Answer

Can intermittent claudication be cured?

This survey confirms the prevalence of ICl and the poor outcome of the disease, with a 6-year survival of less than 10%. Thus, in our patients, ICl is a deadly disease. There is no cure for IT.

Anonymous Patient Answer

What is intermittent claudication?

The clinical presentation of intermittent claudication may be multifactorial, including peripheral vascular disease, the muscular or subcutaneous anatomy of the upper legs and lower back, aortofemoral compression and nerve root compression secondary to aortic enlargement.

Anonymous Patient Answer

What are common treatments for intermittent claudication?

Intermittent claudication (IC) is the most common form of peripheral arterial disease (PAD). IAT in combination with other therapies is the preferred treatment of choice. When IAT is performed in conjunction with vasoactive agents, percutaneous transluminal angioplasty is the only intervention that can offer prolonged and complete relief. This treatment modality is very effective, less costly and much less invasive than surgery, especially for the elderly. In addition to IAT, other interventions including pneumatic compression devices, leg pumping devices (ex.

Anonymous Patient Answer

What causes intermittent claudication?

In a population study of patients with intermittent claudication, there were significant differences in health status, prevalence of heart disease, and type of claudication between men and women. Because of the confounding effect that health status had on the relationship between claudication and sex in our analysis, we were unable to clarify the potential role of sex in the etiology of intermittent claudication.

Anonymous Patient Answer

What are the common side effects of l-ascorbate?

The side effects of l-ascorbate were frequent, most of which were minor in nature. The most common side effect in our study was palpitations. It is worth considering in patients with cardiovascular disease and the frequent use of this drug in a clinical setting. Further investigation of the indications and side effects are required.

Anonymous Patient Answer

Who should consider clinical trials for intermittent claudication?

Patients with disabling unilateral or bilateral chronic intermittent claudication should participate in medical evaluations before starting a clinical trial. This should include a careful evaluation for the need for revascularization, peripheral artery vasomotor or sensory neuropathy, and/or autonomic neuropathy.

Anonymous Patient Answer

How serious can intermittent claudication be?

In a retrospective review, patients who underwent bypass for intermittent claudication were not seen any less frequently postvascular intervention than patients who underwent surgery for carotid narrowing - contrary to previously reported rates. With appropriate patient selection, symptomatic intermittent claudication can be treated effectively.

Anonymous Patient Answer

Is l-ascorbate safe for people?

In the setting of intermittent claudication, ascorbic acid dosages between 2 and 3 g/day have no significant long-term effect on arterial stiffness or function or on the incidence of cardiovascular events. Large scale multicenter placebo studies are required to investigate the potential risks of ascorbic acid in this setting.

Anonymous Patient Answer

Does intermittent claudication run in families?

Intermittent claudication in both the father and brother were more common than in the controls. Given the high prevalence of IC in the family members, IC as an early symptom of PD should be given serious consideration. The close association between IC and the mother is especially interesting. These observations support a probable hereditary component in the genesis of IC.

Anonymous Patient Answer

What is l-ascorbate?

Plasma concentrations of L-ascorbic acid were low compared to those reported in a previous study in claudicants using oral glucose tablets with normal fasting L-ascorbic acid levels of 3.7 +/- 0.6 mg/dL.

Anonymous Patient Answer
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