SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs
Running, not enrolling
Conditions studied: Peripheral Arterial Disease
In brief
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.
Key facts
- Study ID
- NCT04710563
- Run by
- Yale University
- People needed
- 458
- Starts
- 2021-08-11
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All race/ethnicity categories, English speaking, men and women
- Patient presents with current (within 30 days) Rutherford Class 4, 5, or 6
- Age ≥18 years
- 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
You may not qualify if…
- Acute limb ischemia
- Unable to provide written informed consent
- Currently a prisoner (identified at time of enrollment)
Where it is running
- Yale New Haven Health — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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