MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06409949
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)
  • QOL Survey — OTHER
    Assessment of quality of life: Survey of Quality of life with the Walking Impairment Questionnaire and Short Form 36
  • Ankle pressure at rest and after stress — DIAGNOSTIC_TEST
    Assessment of leg hemodynamics: Evaluation of post-occlusive ankle pressure and ankle/brachial index
  • Muscle Oxygen — DIAGNOSTIC_TEST
    Evaluation of calf muscle heme oxygen saturation
  • Serum MitoQ Level — DIAGNOSTIC_TEST
    Evaluation of serum concentrations of MitoQ
  • Needle Biopsy — PROCEDURE
    Needle biopsy of the calf muscle

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MitoQ
    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
  • Placebo Comparator: Placebo
    The patients will take two identical caps of matched placebo on empty stomach, each morning

Primary Outcome Measure

Walking Impairment: maximum treadmill distance [ Time Frame: Before and After 6 months of treatment with MitoQ or placebo ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Medical CenterOmahaNebraska68105
Holly DeSpiegelaere
[email protected]
402-995-4171

Find similar trials in Omaha, NE

By research site
VA Medical Center· Omaha, NE

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