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

Critical Limb Ischemia Clinical Trial

— SCOPE CLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171259
• Other study ID #: 17-054
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

Intervention

Other:
• care as usual
The investigators will be following patients with critical limb ischemia and documenting the usual care that the participants receive.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. La — View Citation

Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: Analysis of amputation free and overall survival by treatment received. J Vasc Surg. 2010 May;51(5 Suppl):18S-31S. doi: 10.1016/j.jvs.2010.01.074. Erratum In: J Vasc Surg. 2010 Dec;52(6):1751. Bhattachary, V [corrected to Bhattacharya, V]. — View Citation

Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Am Heart J. 2004 Feb;147(2):301-8. doi: 10.1016/j.ahj.2003.08.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLI-specific health status	Peripheral Artery Questionnaire-CLI version	12 months
Secondary	Freedom from major amputation or major reintervention	Freedom from major amputation or major peripheral vascular reintervention (surgical or angioplasty)	12 months