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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04710563
Study type Observational [Patient Registry]
Source Yale University
Contact Avis Harper Brooks, MA
Phone 203-737-7673
Email avis.harperbrooks@yale.edu
Status Recruiting
Phase
Start date August 11, 2021
Completion date September 2028
View Details
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