NCT04089943

Brief 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. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

September 10, 2019

Last Update Submit

February 19, 2026

Conditions

Vascular Diseases, PeripheralArterial Occlusive DiseasesAtherosclerosisPeripheral Arterial Disease

Keywords

peripheral artery diseasemicroRNA

Outcome Measures

Primary Outcomes (2)

  • miR-210 gene expression

    Measure miR-210 gene expression at baseline and after intervention

    Change from baseline to six-month follow-up

  • Calf muscle biopsy biochemical measures

    A skeletal muscle sample will be obtained from the gastrocnemius muscle.

    Change from baseline to six-month follow-up

Secondary Outcomes (4)

  • Six-minute walk performance

    Change from baseline to six-month follow-up

  • Graded treadmill walk performance

    Change from baseline to six-month follow-up

  • The 36-Item Short Form questionnaire (SF-36)

    Change from baseline to six-month follow-up

  • The Walking Impairment Questionnaire

    Change from baseline to six-month follow-up

Study Arms (2)

Revascularization group

EXPERIMENTAL

Participants will be randomized to either an endovascular or an open bypass procedure.

Procedure: Revascularization operation

Control group

OTHER

Healthy non-PAD participants will be recruited as control group

Other: Control group

Interventions

Revascularization operationPROCEDURE

Participants will be randomized into an endovascular or open bypass procedure.

Revascularization group
Control groupOTHER

Healthy non-PAD participants will be recruited for the study.

Control group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Austing Dell Medical School

Austin, Texas, 78712, United States

Location

Baylor Scott and White

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesArterial Occlusive DiseasesAtherosclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ArteriosclerosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Panagiotis Koutakis, PhD

    University of West Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 13, 2019

Study Start

September 15, 2019

Primary Completion

August 29, 2024

Study Completion

August 25, 2025

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)