Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT07201168
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Structured Educational Program vs Standard Care in Pre-surgical Critical Limb Ischemia Patients
Sponsor:
Tulip Medicine
Organization:
Study Overview
Official Title:
Impact of a Structured Multimodal Educational Program on Clinical Outcomes and Quality of Life in Patients With Critical Limb Ischemia: A Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: