MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

NCT06409949 | Recruiting

• 1 other identifier: 0053-23-EP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In our research, we are delving into whether taking MitoQ for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. We will be checking if MitoQ helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Walking Impairment: maximum treadmill distance

  Evaluation of maximum walking distance on treadmill until participant chooses to stop due to pain in his legs.

  Before and After 6 months of treatment with MitoQ or placebo

Secondary Outcomes (13)

• Walking Impairment: 6 minute distance

  Before and after 6 months of treatment with MitoQ or placebo

• Walking Impairment: initial claudication treadmill distance

  Before and after 6 months of treatment with MitoQ or placebo

• Walking Impairment: daily physical activity

  Before and after 6 months of treatment with MitoQ or placebo

• Walking Impairment Questionnaire

  Before and after 6 months of treatment with MitoQ or placebo

• Walking Impairment Short Form-36

  Before and after 6 months of treatment with MitoQ or placebo

Study Arms (2)

MitoQ

ACTIVE COMPARATOR

Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning

Diagnostic Test: Walking assessment; Other: QOL Survey; Diagnostic Test: Ankle pressure at rest and after stress; Diagnostic Test: Muscle Oxygen; Diagnostic Test: Serum MitoQ Level; Procedure: Needle Biopsy

Placebo

PLACEBO COMPARATOR

The patients will take two identical caps of matched placebo on empty stomach, each morning

Diagnostic Test: Walking assessment; Other: QOL Survey; Diagnostic Test: Ankle pressure at rest and after stress; Diagnostic Test: Muscle Oxygen; Diagnostic Test: Serum MitoQ Level; Procedure: Needle Biopsy

Interventions

Ankle pressure at rest and after stress DIAGNOSTIC_TEST

Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index

MitoQ; Placebo

Serum MitoQ Level DIAGNOSTIC_TEST

Evaluation of serum concentrations of MitoQ

MitoQ; Placebo

Needle Biopsy PROCEDURE

Needle biopsy of the calf muscle

MitoQ; Placebo

Walking assessment DIAGNOSTIC_TEST

Participating patients will undergo the following evaluations at baseline and after six months of treatment with MitoQ or placebo: Assessment of walking impairment: Evaluation of treadmill maximum walking distances, six-minute walking distance, and daily physical activity (average steps taken daily)

MitoQ; Placebo

QOL Survey OTHER

Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36

MitoQ; Placebo

Muscle Oxygen DIAGNOSTIC_TEST

Evaluation of calf muscle heme oxygen saturation

MitoQ; Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a positive history of chronic claudication
• exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
• documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging
• stable blood pressure, lipid and diabetes regimens and risk factor control for 6 weeks.

You may not qualify if:

• rest pain or tissue loss due to PAD (Fontaine stage III and IV)
• acute lower extremity ischemic event
• walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

VA Medical Center

Omaha, Nebraska, 68105, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Iraklis Pipinos, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly DeSpiegelaere, BSN RN CCRC

CONTACT

402-995-4171; Holly.DeSpiegelaere@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, randomized, placebo-controlled trial with two parallel arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with peripheral artery disease and claudication will participate in a double-blind, randomized, placebo-controlled trial with two parallel arms. Patients will be randomized 2:1 to receive either a daily oral dose of 40 mg MitoQ or matched placebo for six months.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)