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

NCT07201168 | Completed

• 1 other identifier: NROC 3
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

critical limb ischemia; peripheral artery disease; patient education; structured education program; quality of life; chronic limb threatening ischemia; health education; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Frequency of CLI-related hospitalizations

  Total number of hospitalizations related to critical limb ischemia or its complications (such as limb infections, need for revascularization, amputation) per patient during the follow-up period.

  12 months from enrollment

• SF-12 Quality of Life Score

  12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS): 0-100 Mental Component Summary (MCS): 0-100 Higher scores indicate better quality of life and better health status.

  Baseline, 6 months, and 12 months from enrollment

Secondary Outcomes (5)

• Visual Analog Scale (VAS) Pain Score

  Baseline, 6 months, and 12 months from enrollment

• Proportion of disability cases

  12 months from enrollment

• Smoking cessation rate

  12 months from enrollment

• Pain-free walking distance

  Baseline, 12 months from enrollment

• Quality-Adjusted Life Years (QALY)

  12 months from enrollment

Study Arms (2)

Educational Program + Standard Medical Care

EXPERIMENTAL

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.

Other: Structured Multimodal Educational Program for Critical Limb Ischemia

Standard Medical Care

OTHER

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.

Other: Standard medical care

Interventions

Standard medical care 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.

Standard Medical Care

Structured Multimodal Educational Program for Critical Limb Ischemia 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.

Educational Program + Standard Medical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulip Medicine: lead

Study Sites (1)

NCJSC "Astana Medical University"

Astana, Kazakhstan

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 1, 2025
• Study Start: September 30, 2024
• Primary Completion: December 26, 2025
• Study Completion: December 26, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)