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New treatment option for Peripheral Artery Disease
Official title Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
ClinicalTrials.gov ID: NCT06319339
What this study is testing
What is Vumerity?
Vumerity is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peripheral artery disease.
Also referred to as diroximal fumarate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.