SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)
Key facts
- Who runs it
- Saint Luke's Health System
- Where
- Cleveland and New Haven, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 80 people enrolled
- Started
- 1 Jan 2020
- Ended
- 31 Dec 2023
- Type of study
- Observational
- Treatments tested
- care as usual
- Record updated
- 24 May 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- All race/ethnicity categories, English or Spanish speaking, men and women
- Age ≥18 years
- Patients presenting with Rutherford Classification 4 (ischemic rest pain), or Rutherford Classification 5 (minor tissue loss: non-healing ulcer, focal gangrene with diffuse pedal ischemia), or Rutherford Classification 6 (major tissue loss: extending above transmetatarsal level, functional foot no longer salvageable) at specialty clinics will prospectively be screened, regardless of whether the patient undergoes endovascular, bypass, amputation, and/or medical therapy
- Diagnosis is supported by any of the following hemodynamic parameters (assessed pre- procedurally): Ankle pressure lower than 70 mmHg; Toe pressure lower than 50 mmHg or evidence of ischemia by transcutaneous oxygen measurement (tcpO2) <40 or a skin perfusion pressure (SPP) <40 or angiographic evidence of significant vascular disease
Who cannot take part
- No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the enrollment
- Acute limb ischemia
- Unable to provide written informed consent
- Currently a prisoner
Where in United States
- University Hospitals ClevelandCleveland, United StatesNo longer taking part
- Yale New Haven HospitalNew Haven, United StatesNo longer taking part
About the trial
What the trial wants to find out
Given the importance of understanding CLI patients' outcomes and existing gaps in knowledge, there is a pressing need to collect observational data on treatment patterns, adherence to performance measures, and outcomes that are relevant to patients and clinicians. To address this need, the current study will pilot test the research infrastructure and data elements needed to build a larger, national study collecting of the CLI population. It will also provide much-needed preliminary information to identify areas of action that can be targeted in quality improvement programs for this population. Most importantly, it will provide data on health status outcomes in patients with CLI, as a function of individual patient characteristics (demographics, socio-economic and clinical background) and the treatments that patients have undergone. The PORTRAIT-CLI study will also be well equipped to identify potential disparities in the provision of care and patients' outcomes as a function of patient's characteristics.
Treatments tested
- care as usual
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs- Critical Limb Ischemia)
- Record updated
- 24 May 2024