Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
This study is currently recruiting participants.
Verified October 2012 by University of Washington
Sponsor:
University of Washington
Information provided by (Responsible Party):
David Flum, University of Washington
ClinicalTrials.gov Identifier:
NCT01378260
First received: June 13, 2011
Last updated: October 24, 2012
Last verified: October 2012
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Purpose
The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses;
Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management.
Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.
| Condition |
|---|
|
Peripheral Arterial Disease Claudication |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD) |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment. [ Time Frame: 12-Months Post-Index Date ] [ Designated as safety issue: No ]The primary outcome of the study, and the outcome on which the study is powered, is the change in score on the WIQ from the baseline assessment to the 12-month assessment. There are three subscales within the WIQ; summary scores will be calculated separately for each - the walk distance, walk speed, stair climb.
| Estimated Enrollment: | 1100 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Surgical Bypass
use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery
|
|
Endovascular Therapy
angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery
|
|
Medical Management
Documentation of the following in the medical record: i. Walking/physical therapy to improve endurance was recommended; ii. For tobacco users, tobacco cessation was recommended; iii. Prescribing pentoxifylline (Trental) or cilostazol (pletal) iv. Ongoing care by physician for treatment of claudication |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients being seen by a physician with newly diagnosed or established claudication
Criteria
Inclusion Criteria:
- Diagnosis of claudication
Be undergoing one of three treatments for claudication:
- Surgical bypass (use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral or popliteal artery)
- Endovascular therapy (angioplasty and/or stent to treat lesions in the superficial femoral, common femoral or popliteal artery)
- Medical management (i.e. smoking cessation, walking therapy, long-term monitoring by physician)
Exclusion Criteria:
- those with documented acute ischemia, rest pain or ulceration
- those with claudication determined to be of aortic or iliac origin
- those with claudication that is not caused by atherosclerotic disease
- those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
- those who otherwise refuse to participate (assessed in patient screen)
- those who have a diagnosis of dementia confirmed in their medical record
- those who are not English speaking
- children and young adults up to and including age 20-years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378260
Contacts
| Contact: Sondra Johnson | 206-616-0474 | sondraj@uw.edu |
Locations
| United States, Washington | |
| Grays Harbor Community Hospital | Withdrawn |
| Aberdeen, Washington, United States, 98520 | |
| Lake Washington Vascular | Recruiting |
| Bellevue, Washington, United States, 98004 | |
| Principal Investigator: David R Flum, MD | |
| PeaceHealth St. Joseph Medical Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Principal Investigator: David R Flum, MD | |
| St. Francis Hospital | Recruiting |
| Federal Way, Washington, United States, 98003 | |
| Principal Investigator: David R Flum, MD | |
| Good Samaritan Hospital | Recruiting |
| Puyallup, Washington, United States, 98372 | |
| Principal Investigator: David R Flum, MD | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Sondra Johnson 206-616-0474 sondraj@uw.edu | |
| Principal Investigator: David R Flum, MD | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Sondra Johnson 206-616-0474 sondraj@uw.edu | |
| Principal Investigator: David R Flum, MD, MPH | |
| Northwest Hospital and Medical Center | Recruiting |
| Seattle, Washington, United States, 98133 | |
| Principal Investigator: David R Flum, MD | |
| Providence Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Principal Investigator: David R Flum, MD | |
| Tacoma General Hospital | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Principal Investigator: David R Flum, MD | |
| St. Joseph Medical Center | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Principal Investigator: David R Flum, MD | |
Sponsors and Collaborators
University of Washington
Investigators
| Principal Investigator: | David R Flum, MD | University of Washington |
More Information
No publications provided
| Responsible Party: | David Flum, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01378260 History of Changes |
| Other Study ID Numbers: | 40153-D, R01HS2002501 |
| Study First Received: | June 13, 2011 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Peripheral Arterial Disease Claudication Comparative Effectiveness Research PAD Study |
PAD atherosclerosis Intermittent claudication leg pain |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Peripheral Vascular Diseases Intermittent Claudication Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013