Peripheral Arterial DiseaseNCT04089943
The Role of microRNA-210 in Regulating Oxidative Stress in Patients With PAD
A study testing Revascularization operation in people with Peripheral Arterial Disease and Vascular Diseases, Peripheral, run by University of West Florida at 2 sites in United States.
Trial summary
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases
- What is being tested?
- Revascularization operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2019to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female 30 years or older,
- Infrainguinal PAD,
- critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent,
- candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons,
- absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms,
- willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Who cannot join
- life expectancy of less than 2 years due to reasons other than PAD,
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
- current chemotherapy or radiation therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Austing Dell Medical School
Austin, Texas, 78712
Baylor Scott and White
Temple, Texas, 76508
About this study
Official title: The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
Read the detailed description
The investigators will randomize 180 PAD patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. They are also planning to recruit 50 non-PAD healthy control subjects.
The goal is to answer the main hypothesis that miR-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases, Atherosclerosis
- Being tested
- Revascularization operation, Control group
- Keywords
- peripheral artery disease, microRNA
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization operationProcedure or surgery
Participants will be randomized into an endovascular or open bypass procedure.
Control groupOther
Healthy non-PAD participants will be recruited for the study.
| Study group | Role | What they receive |
|---|---|---|
| Revascularization group | Experimental | Participants will be randomized to either an endovascular or an open bypass procedure. Receives: Procedure: Revascularization operation |
| Control group | Other | Healthy non-PAD participants will be recruited as control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-210 gene expression
Measure miR-210 gene expression at baseline and after intervention
Measured: Change from baseline to six-month follow-up
Calf muscle biopsy biochemical measures
A skeletal muscle sample will be obtained from the gastrocnemius muscle.
Measured: Change from baseline to six-month follow-up
Secondary outcomes (4)
Six-minute walk performance
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Measured: Change from baseline to six-month follow-up
Graded treadmill walk performance
Participants walking on treadmill following a standardized protocol. The goal is for them to walk as far as possible while the treadmill incline increases every 2 minutes.
Measured: Change from baseline to six-month follow-up
The 36-Item Short Form questionnaire (SF-36)
This well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score.
Measured: Change from baseline to six-month follow-up
The Walking Impairment Questionnaire
The well validated Walking Impairment Questionnaire (WIQ) will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score.
Measured: Change from baseline to six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start15 Sep 2019
- Primary completion29 Aug 2024
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Panagiotis Koutakis, University of West Florida
- Investigators
- Panagiotis Koutakis, PhD, Principal investigator, University of West Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089943
- Sponsor's protocol ID
- 2211301
- Other IDs
- 1R01AG064420
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2019
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT04089943
- Acronym / sponsor ID
- 2211301
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Peripheral, Arterial Occlusive Diseases, Atherosclerosis
- Keywords
- peripheral artery disease, microRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of West FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
Detailed description
The investigators will randomize 180 PAD patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. They are also planning to recruit 50 non-PAD healthy control subjects.
The goal is to answer the main hypothesis that miR-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization group | Experimental | Procedure: Revascularization operationParticipants will be randomized to either an endovascular or an open bypass procedure. |
| Control group | Other | Other: Control groupHealthy non-PAD participants will be recruited as control group |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female 30 years or older,
- Infrainguinal PAD,
- critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent,
- candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons,
- absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms,
Key exclusion criteria (3 listed)
- life expectancy of less than 2 years due to reasons other than PAD,
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
- current chemotherapy or radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revascularization operationParticipants will be randomized into an endovascular or open bypass procedure. | Procedure or surgery | Revascularization group |
| Control groupHealthy non-PAD participants will be recruited for the study. | Other | Control group |
Primary outcome
miR-210 gene expression
Time frame: Change from baseline to six-month follow-up
Measure miR-210 gene expression at baseline and after intervention
Calf muscle biopsy biochemical measures
Time frame: Change from baseline to six-month follow-up
A skeletal muscle sample will be obtained from the gastrocnemius muscle.
4 secondary outcomes
Six-minute walk performance
Time frame: Change from baseline to six-month follow-up
Graded treadmill walk performance
Time frame: Change from baseline to six-month follow-up
The 36-Item Short Form questionnaire (SF-36)
Time frame: Change from baseline to six-month follow-up
The Walking Impairment Questionnaire
Time frame: Change from baseline to six-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Koutakis, PhD principal investigator
University of West Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization operation in people with Peripheral Arterial Disease and Vascular Diseases, Peripheral, run by University of West Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miR-210 gene expression (time frame: Change from baseline to six-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.