NCT01970332

Brief Summary

Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

5.7 years

First QC Date

September 4, 2013

Last Update Submit

September 1, 2023

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial DiseasePeripheral Vascular DiseaseClaudicationMyopathyOxidative stressMitochondrial dysfunctionBiomechanicsInflammation

Outcome Measures

Primary Outcomes (4)

  • Walking distances

    Initial Claudication Distance, Absolute Claudication Distance, 6-Minute Walking Distance

    six months

  • Quality of life Questionnaires

    Walking Impairment Questionnaire and the Medical Outcomes Study Short Form 36 Healthy Survey

    six months

  • Leg biomechanics

    Propulsion Impulse, Ankle plantarflexor torque, Ankle plantarflexor power and maximum isometric plantarflexion force

    six months

  • Leg hemodynamics

    Ankle Brachial Index

    6 months

Secondary Outcomes (4)

  • Myofiber Mitochondrial Function

    6 months

  • Myofiber Oxidative Damage

    6 months

  • Muscle inflammation

    6 months

  • Myofiber Morphology

    6 months

Study Arms (3)

No Exercise Therapy or Revascularization operation

NO INTERVENTION

The patient is evaluated but no intervention

Revascularization Surgery

EXPERIMENTAL

The patient undergoes surgery to revascularize the ischemic, symptomatic limb(s)

Other: Supervised exercise therapy

Exercise Therapy

EXPERIMENTAL

The patient undergoes supervised exercise therapy for 6 months

Procedure: Revascularization Surgery

Interventions

Revascularization SurgeryPROCEDURE
Exercise Therapy
Supervised exercise therapyOTHER
Revascularization Surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), 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
  • an ankle/brachial index \< 0.90 at rest

You may not qualify if:

  • absence of Peripheral Arterial Disease (PAD)
  • acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
  • exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center, Omaha

Omaha, Nebraska, 68105, United States

Location

Related Publications (1)

  • Rahman H, Leutzinger T, Hassan M, Schieber M, Koutakis P, Fuglestad MA, DeSpiegelaere H, Longo GM, Malcolm P, Johanning JM, Casale GP, Pipinos II, Myers SA. Peripheral artery disease causes consistent gait irregularities regardless of the location of leg claudication pain. Ann Phys Rehabil Med. 2024 Apr;67(3):101793. doi: 10.1016/j.rehab.2023.101793. Epub 2023 Dec 20.

    PMID: 38118246DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesIntermittent ClaudicationMuscular DiseasesMitochondrial DiseasesInflammation

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • Iraklis I Pipinos, MD, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

October 28, 2013

Study Start

September 1, 2010

Primary Completion

May 30, 2016

Study Completion

May 30, 2016

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

US(1)