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

NCT ID: NCT07201168

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-09-03

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Educational Program + Standard Medical Care

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.

Group Type: EXPERIMENTAL

Structured Multimodal Educational Program for Critical Limb Ischemia

Intervention Type: OTHER

A comprehensive 4 weeks educational program combining face-to-face and digital learning modalities. Components include: interactive group sessions twice a week led by vascular specialists covering the pathophysiology of disease, risk factor modification, and treatment options; digital platform access with multimedia educational materials, printed educational materials for home reference; peer support group participation; medical hotline access for patient-initiated consultations and urgent questions; smoking cessation counseling; supervised exercise program recommendations; wound care training. The program emphasizes patient self-management skills, early recognition of complications, and adherence to medical therapy alongside standard clinical care.

Standard Medical Care

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.

Group Type: OTHER

Standard medical care

Intervention Type: OTHER

Routine clinical management for critical limb ischemia according to current standard of care guidelines. Includes vascular surgery consultation and scheduled follow-up appointments as clinically indicated. No structured educational materials, formal patient education sessions, or additional follow-up contacts beyond routine clinical care are provided. Patients receive standard verbal and written instructions during consultation and have access to the same medical and surgical treatments as the intervention group when clinically warranted.

Interventions

Structured Multimodal Educational Program for Critical Limb Ischemia

A comprehensive 4 weeks educational program combining face-to-face and digital learning modalities. Components include: interactive group sessions twice a week led by vascular specialists covering the pathophysiology of disease, risk factor modification, and treatment options; digital platform access with multimedia educational materials, printed educational materials for home reference; peer support group participation; medical hotline access for patient-initiated consultations and urgent questions; smoking cessation counseling; supervised exercise program recommendations; wound care training. The program emphasizes patient self-management skills, early recognition of complications, and adherence to medical therapy alongside standard clinical care.

Intervention Type: OTHER

Standard medical care

Routine clinical management for critical limb ischemia according to current standard of care guidelines. Includes vascular surgery consultation and scheduled follow-up appointments as clinically indicated. No structured educational materials, formal patient education sessions, or additional follow-up contacts beyond routine clinical care are provided. Patients receive standard verbal and written instructions during consultation and have access to the same medical and surgical treatments as the intervention group when clinically warranted.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulip Medicine

OTHER

Sponsor Role: lead

Responsible Party

Didar Khassenov

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NCJSC "Astana Medical University"

Astana, , Kazakhstan

Countries

Kazakhstan

Other Identifiers

NROC 3

Identifier Type: -

Identifier Source: org_study_id