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

Tulip Medicine

Status: Completed

Conditions: Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Health Education

Treatments: Other: Standard medical care; Other: Structured Multimodal Educational Program for Critical Limb Ischemia

Study type: Interventional

Funder types: Other

Identifiers

NCT07201168

NROC 3

Details and patient eligibility

About

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.

Full description

This randomized controlled trial evaluates the effectiveness of a structured multimodal educational program (School of Critical Limb Ischemia) compared to standard medical care in improving clinical outcomes for patients with critical limb ischemia (CLI).

Modifiable risk factors including smoking, physical inactivity, uncontrolled diabetes, hypertension, and dyslipidemia play crucial roles in disease progression. Research demonstrates that comprehensive risk factor modification significantly improves outcomes-patients who quit smoking have 14% five-year mortality compared to 31% among continued smokers. Despite this evidence, patient adherence remains low, with only 5-30% successfully quitting smoking and fewer than 50% engaging in recommended exercise programs.

Educational interventions have proven effective in other chronic conditions such as diabetes and heart failure, improving patient self-management and clinical outcomes. However, significant knowledge gaps exist among CLI patients-only 54% are aware of multiple treatment options, 24% incorrectly believe no additional treatment is needed after surgery, and only 31% understand the priority of conservative therapy over invasive interventions. This highlights the critical need for structured educational programs specifically designed for CLI patients.

The intervention combines traditional face-to-face education with digital technologies to create a personalized, accessible learning experience addressing disease understanding, risk factor modification, symptom recognition and management, and shared decision-making. The program utilizes interactive group sessions, individual counseling, digital platforms with multimedia materials, printed resources, peer support, and regular follow-up contact. Participants are randomly assigned to receive either the educational program plus standard medical care or standard medical care alone, with 12-month follow-up to assess both short-term and medium-term outcomes.

If successful, this research could transform CLI management by providing evidence for implementing structured educational programs in vascular surgery practices. Given the substantial economic burden of CLI treatment (estimated at USD 24,000-72,000 per patient in the first year), even modest improvements in clinical and economic outcomes could result in significant healthcare cost savings.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Confirmed diagnosis of chronic critical limb ischemia (CLI)
• Rutherford category 2-5
• Ability to understand study procedures and provide signed and dated written informed consent
• Fluency in Russian language
• Access to telephone and internet

Exclusion criteria

• Severe cognitive impairment
• Participation in another clinical trial that might interfere with study outcomes
• Planned major amputation within 3 months
• Diabet 1 and 2 type
• Inability to attend scheduled educational sessions
• Severe visual or hearing impairments that would interfere with participation in educational sessions
• Patients who declined to participate after being informed about the study protocol

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Educational Program + Standard Medical Care

Experimental group

Description:

Participants receive a comprehensive 4-week multimodal educational program including interactive group sessions, digital platform access, printed materials, and medical hotline access in addition to standard medical care.

Treatment:

Other: Structured Multimodal Educational Program for Critical Limb Ischemia

Standard Medical Care

Other group

Description:

Participants receive standard medical care for critical limb ischemia including routine vascular surgery consultation, standard medical management, and usual wound care instructions without any structured educational intervention.

Treatment:

Other: Standard medical care