Chronic Limb-Threatening IschemiaNCT07201168
Structured Educational Program vs Standard Care in Pre-surgical Critical Limb Ischemia Patients
A study testing Structured Multimodal Educational Program for Critical Limb Ischemia and Standard medical care in people with Chronic Limb-Threatening Ischemia and Peripheral Arterial Disease, run by Tulip Medicine at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Health Education
- What is being tested?
- Structured Multimodal Educational Program for Critical Limb Ischemia and Standard medical care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteKazakhstan
- Study dates
- 30 Sep 2024to 26 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Being tested
- Structured Multimodal Educational Program for Critical Limb Ischemia, Standard medical care
- Keywords
- critical limb ischemia, peripheral artery disease, patient education, structured education program, quality of life, chronic limb threatening ischemia, health education, randomized controlled trial
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Multimodal Educational Program for Critical Limb IschemiaOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months from enrollment
Secondary outcomes (5)
Visual Analog Scale (VAS) Pain Score
Pain intensity assessed using the Visual Analog Scale (VAS). Score range: 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Measured: Baseline, 6 months, and 12 months from enrollment
Proportion of disability cases
Percentage of new disability cases or changes in disability status during the follow-up period.
Measured: 12 months from enrollment
Smoking cessation rate
Percentage of patients who successfully quit smoking at 12 months follow-up among those who were smokers at baseline, defined as self-reported abstinence from smoking in the past month.
Measured: 12 months from enrollment
Pain-free walking distance
Distance walked before onset of leg pain assessed by smartphone pedometer during standardized walking test at self-selected comfortable pace until onset of claudication pain.
Measured: Baseline, 12 months from enrollment
Quality-Adjusted Life Years (QALY)
Health utility measured using SF-6D utility scores derived from SF-12 questionnaire, calculated using the area under the curve method over the 12-month study period The QALY score will range from 0 to 1. A higher QALY score represents a better overall health outcome over the 12-month period, indicating more time spent in a better state of health.
Measured: 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start30 Sep 2024
- Primary completion26 Dec 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulip Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didar Khassenov, Tulip Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201168
- Sponsor's protocol ID
- NROC 3
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07201168
- Acronym / sponsor ID
- NROC 3
- Keywords
- critical limb ischemia, peripheral artery disease, patient education, structured education program, quality of life, chronic limb threatening ischemia, health education, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Tulip MedicineUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Program + Standard Medical Care | Experimental | Other: Structured Multimodal Educational Program for Critical Limb IschemiaParticipants 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. |
| Standard Medical Care | Other | Other: Standard medical careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Multimodal Educational Program for Critical Limb IschemiaA 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. | Other | Educational Program + Standard Medical Care |
| Standard medical careRoutine 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. | Other | Standard Medical Care |
Primary outcome
Frequency of CLI-related hospitalizations
Time frame: 12 months from enrollment
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.
SF-12 Quality of Life Score
Time frame: Baseline, 6 months, and 12 months from enrollment
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.
5 secondary outcomes
Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 6 months, and 12 months from enrollment
Proportion of disability cases
Time frame: 12 months from enrollment
Smoking cessation rate
Time frame: 12 months from enrollment
Pain-free walking distance
Time frame: Baseline, 12 months from enrollment
Quality-Adjusted Life Years (QALY)
Time frame: 12 months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Multimodal Educational Program for Critical Limb Ischemia and Standard medical care in people with Chronic Limb-Threatening Ischemia and Peripheral Arterial Disease, run by Tulip Medicine at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of CLI-related hospitalizations (time frame: 12 months from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.