SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs (SCOPE-CLI)

October 16, 2025 updated by: Yale University

SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia

A research project capturing experiences of patients with critical limb threatening ischemia, with the ultimate goal of setting new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD). One of its extreme expressions is Critical Limb Ischemia (CLI). It is one of the most severe vascular conditions associated with devastating outcomes, including poorly healing wounds, extreme pain, and a high amputation risk. It is also one of the deadliest conditions, with 6-month and 5-year mortality rates estimated to be 20 and >50%, respectively. To date, however, there is a paucity of prospective clinical evidence about the variability in patients' presentations, their management or their outcomes. Accordingly, little progress has been made in adequately staging the disease and to risk-stratify treatment approaches to patients' individual characteristics. What is desperately needed to advance the care and management of patients with CLI is a focused research effort to set new standards for diagnosing, describing detailed patient-centered outcomes, and evaluating the variability in therapeutic approaches and their association with outcomes. The specific aims of SCOPE-CLI are to generate new evidence on the clinical characteristics, treatment patterns and outcomes of patients with critical limb ischemia (CLI); to describe treatment patterns and variability across practices to identify gaps in delivering quality care; and to perform a series of analyses to examine the associations of patient and treatment characteristics with outcomes. The central objective of SCOPE-CLI is to systematically quantify patients' CLI-specific health status and clinical outcomes and to perform subgroup analyses as a function of different PAD treatments and patient characteristics.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be enrolled from a range of clinical practices combining forces from vascular surgery, vascular medicine (interventional) cardiology, wound care specialists and podiatry clinics that treat CLI patients. All patients will be medically stable, i.e., not actively experiencing a life-threatening critical condition for which emergent care processes are ongoing, before they are approached for inclusion in the study.

Description

Inclusion Criteria:

  1. All race/ethnicity categories, English speaking, men and women
  2. Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6
  3. Age ≥18 years

  4. Supported by any of the following diagnostic evidence:

    • Rutherford Classification 4 or ischemic rest pain and/or resting ankle pressure <50mmHg, flat or barely pulsatile ankle or metatarsal PVR or toe pressure <40mmHg
    • Rutherford Classification 5 or minor tissue loss; non-healing ulcer, focal gangrene with diffuse pedal ischemia resting ankle pressure <50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure <40mmHg
    • Rutherford Classification 6 or major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable, resting ankle pressure <50mmHg ankle or metatarsal PVR flat or barely pulsatile or toe pressure <40mmHg
    • CLI related ICD 10 code (reason for admission or indication for procedure)
    • SPP < 50 mmHg
    • TCPO2 < 50 mmHg
    • Angiographic evidence no straight line to foot or greater than 70% stenosis in all 3 lower extremity arteries (AT, PT, peroneal)
    • ABI* ≤ 0.90
    • non-compressible ABI ≥ 1.40 AND TBI ≤ 0.70
    • TBI* ≤ 0.70

Exclusion Criteria:

  1. Acute limb ischemia
  2. Unable to provide written informed consent
  3. Currently a prisoner (identified at time of enrollment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peripheral Artery Questionnaire (PAQ)
Time Frame: After enrollment and follow-up at month 1
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
After enrollment and follow-up at month 1
Peripheral Artery Questionnaire (PAQ)
Time Frame: After enrollment and follow-up at month 2
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
After enrollment and follow-up at month 2
Peripheral Artery Questionnaire (PAQ)
Time Frame: After enrollment and follow-up at month 6
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
After enrollment and follow-up at month 6
Peripheral Artery Questionnaire (PAQ)
Time Frame: After enrollment and follow-up at month 12
PAD-specific, multi-dimensional health status instrument with a CLI specific module. Higher scores indicate better functioning.
After enrollment and follow-up at month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse limb events (MALE)
Time Frame: 6 months after enrollment
Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)
6 months after enrollment
Major adverse limb events (MALE)
Time Frame: 12 months after enrollment
Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)
12 months after enrollment
Major adverse limb events (MALE)
Time Frame: 5 years after enrollment
Major adverse limb events include: major amputation above the level of the ankle joint, thrombolysis/thrombectomy or surgical bypass or graft revision, after diagnostic or interventional lower extremity angiography)
5 years after enrollment
Amputation Free Survival (AFS)
Time Frame: 6 months after enrollment
AFS will be a measure of number of patients "free from death or above ankle amputation"
6 months after enrollment
Amputation Free Survival (AFS)
Time Frame: 12 months after enrollment
AFS will be a measure of number of patients "free from death or above ankle amputation"
12 months after enrollment
Amputation Free Survival (AFS)
Time Frame: 5 years after enrollment
AFS will be a measure of number of patients "free from death or above ankle amputation"
5 years after enrollment
Mortality - Death
Time Frame: 6 months after enrollment
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died
6 months after enrollment
Mortality - Death
Time Frame: 12 months after enrollment
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died
12 months after enrollment
Mortality - Death
Time Frame: 5 years after enrollment
Vital status obtained from either medical records or social security death index will be assessed to account for number of patients who died
5 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baylor College of Medicine
University of Chicago
Columbia University
Brown University
Janssen Scientific Affairs, LLC
The Cleveland Clinic
Emory University
University of Southern California
University of California, Davis
Oregon Health and Science University
University of Minnesota
Abbott
Saint Luke's Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kim Smolderen, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000028963
  • 000 (Other Identifier: YCTG)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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