PAD patients may get a boost from a single dose of vumerity
NCT ID NCT06319339
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether a single dose of Vumerity (diroximel fumarate) can improve blood vessel function and walking ability in 20 people aged 50-75 with peripheral artery disease (PAD). Participants will receive either Vumerity or a placebo, and researchers will measure changes in blood flow, oxygen use, and treadmill walking distance. The goal is to see if reducing oxidative stress can ease leg pain and improve mobility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vumerity (diroximel fumarate)
- What this could lead to
- If it works, this could point toward a new way to improve walking ability and blood vessel function in people with peripheral artery disease.
- What could go wrong
- This is a very early, small trial with only 20 people, testing just a single dose. The results may not lead to a lasting treatment or apply to everyone with PAD.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: Peripheral artery disease (PAD) participants: * Able to provide written informed consent * 50-75 years of age * Diagnosed as Fontaine stage II-III * History of exercise-induced claudication * Females must be postmenopausal (cessation of menses for \> 24 months) * Normal renal function (serum creatinine-estimated glomerular filtration rate \>= 60 mL/min) or evidence of stable renal function within the last 6 months * Normal hepatic function (alanine transaminase \< 87.5 U/L, alkaline phosphatase \< 260 U/L, total bilirubin 1.8 mg/dL) or evidence of stable hepatic function within the last 6 months * Complete blood count: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months Age-matched control participants: * Able to provide written informed consent * 50-75 years of age * No evidence of peripheral occlusive disease (ankle-brachial index \> 0.90) * Females must be postmenopausal (cessation of menses for \> 24 months) * Normal renal function (serum creatinine-estimated glomerular filtration rate \>= 60 mL/min), or evidence of stable renal function within the last 6 months * Normal hepatic function (alanine transaminase \< 87.5 U/L, alkaline phosphatase \< 260 U/L, total bilirubin 1.8 mg/dL ), or evidence of stable hepatic function within the last 6 months * Complete blood count: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months Exclusion Criteria: Peripheral artery disease (PAD) participants: * • Pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD) * Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma * Limited walking capacity from conditions other than PAD * No physical exam to assess exercise limitations in the past year * Currently pregnant or nursing * Blood work and medical history NOT demonstrating: * Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min) * Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L), * Diagnosis of multiple sclerosis or psoriasis * Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc. * Concomitant use of dimethyl fumarate * Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY * Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD) * Complete blood count NOT within ranges: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L Age-matched control participants: * Positive diagnosis of PAD * No physical exam to assess exercise limitations in the past year * Any exercise limitations as determined at last physical exam * Limited walking capacity from musculoskeletal injury * Currently pregnant or nursing * Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min) * Hepatic function not within normal ranges (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L) * Complete blood count NOT within ranges: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Nebraska - Omaha
RECRUITINGOmaha, Nebraska, 68182, United States
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