CLTI School

Research hypothesis: A structured multimodal educational program (CLTI School) improves clinical outcomes and quality of life in patients with peripheral artery disease (PAD), including chronic limb-threatening ischemia (CLTI), compared to standard care.
About the data: This dataset contains individual-level data from a parallel-group randomized controlled trial (RCT) conducted in Astana, Kazakhstan (ClinicalTrials.gov: NCT07201168). A total of 159 participants with PAD (Rutherford categories 2–5) were followed for 12 months. Data were collected at baseline, 6 months, and 12 months. Variables include SF-12 Physical and Mental Component Summary scores, VAS pain intensity, pain-free walking distance, smoking status, hospitalizations, revascularizations, amputations, and quality-adjusted life years (QALYs) derived from SF-6D utility scores.
Notable findings: The experimental group showed significantly higher SF-12 PCS (44.76 vs. 35.08; p<0.001) and MCS scores (43.42 vs. 35.90; p<0.001) at 12 months. Pain decreased significantly (median VAS 3 vs. 5; p<0.001), smoking cessation was threefold higher (25.0% vs. 8.5%; p=0.026), and QALYs were greater (0.67 vs. 0.60; p<0.001). Amputation and hospitalization rates were numerically lower in the experimental group but did not reach statistical significance, likely due to limited power for rare events.
How to interpret and use the data: Groups are coded as Experimental (CLTI School + standard care) and Control (standard care only). Stratification variable reflects disease severity: Stratum A (Rutherford 2–3, intermittent claudication) and Stratum B (Rutherford 4–5, critical ischemia). Continuous outcomes are non-normally distributed — Mann–Whitney U and Wilcoxon signed-rank tests are appropriate. Categorical outcomes (hospitalizations, smoking, amputation) should be analyzed using chi-square or Fisher's exact test. All analyses were performed in IBM SPSS v27.