Structured Educational Program vs Standard Care in Pre-surgical Critical Limb Ischemia Patients

Critical limb ischemia (CLI) is a severe condition where poor blood flow to the legs causes pain, non-healing wounds, and may require amputation. It affects 10% of people over 40, rising to 20% in those over 70. Within the first year after diagnosis, 30% of patients need amputation and 25% die. Current treatments include medications, surgery to restore blood flow, or amputation, but results remain poor. Research shows that lifestyle changes like quitting smoking and regular exercise can significantly improve outcomes, yet most CLI patients struggle to make these changes and lack knowledge about their condition. This study tests whether a structured educational program called the "Critical Limb Ischemia School" can help patients. The program teaches patients about their condition, symptom management, lifestyle modifications, and when to seek medical help. The investigators will compare patients receiving this education to those getting standard care. The study will evaluate several important health outcomes during a 12-month period to determine if the educational program makes a meaningful difference in patients' lives. The investigators will assess how the intervention affects patients' overall well-being, their ability to manage symptoms and daily activities, and whether it helps prevent serious complications that could lead to disability. If successful, this program could provide a cost-effective way to help CLI patients manage their condition and potentially avoid serious complications like amputation.

NCT Number	NCT07201168
Lead Sponsor	Tulip Medicine
Conditions	Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Health Education
Enrollment	184 participants
Start Date	2024-09-30
Primary Completion	2025-12-26 (estimated)
Study Completion	2025-12-26 (estimated)
Updated on ClinicalTrials.gov	2026-03-10