Status:

COMPLETED

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

Lead Sponsor:

Tulip Medicine

Conditions:

Chronic Limb-Threatening Ischemia

Peripheral Arterial Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 tho...

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 o...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 3 2025

Estimated Enrollment :

184 Patients enrolled

Trial Details

Trial ID

NCT07201168

Start Date

April 1 2024

End Date

September 3 2025

Last Update

December 9 2025

Active Locations (1)

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NCJSC "Astana Medical University"

Astana, Kazakhstan