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MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

NCT06409949 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Walking assessment

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)

OTHER

QOL Survey

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

DIAGNOSTIC_TEST

Ankle pressure at rest and after stress

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

DIAGNOSTIC_TEST

Muscle Oxygen

Evaluation of calf muscle heme oxygen saturation

DIAGNOSTIC_TEST

Serum MitoQ Level

Evaluation of serum concentrations of MitoQ

PROCEDURE

Needle Biopsy

Needle biopsy of the calf muscle

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Iraklis Pipinos, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-10-31
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06409949 on ClinicalTrials.gov