EFFECTIVENESS OF A MULTIMODAL PATIENT EDUCATION PROGRAM IN PATIENTS WITH AND WITHOUT TROPHIC ULCERS OF THE LOWER EXTREMITIES ASSOCIATED WITH PERIPHERAL ARTERY DISEASE

Relevance. Chronic limb-threatening ischemia is the most severe manifestation of peripheral artery disease, carrying high rates of amputation and mortality. Structured patient education programs have demonstrated benefit in other chronic diseases, yet remain largely unevaluated in peripheral artery disease, particularly chronic limb-threatening ischemia.

Objective. To evaluate the effectiveness of a structured multimodal educational program (CLTI School) compared with standard care on clinical outcomes and quality of life in patients with peripheral artery disease.

Materials and Methods. Parallel-group randomized controlled trial conducted in Astana, Kazakhstan. A total of 184 patients with peripheral artery disease (Rutherford categories 2-5) were randomized 1:1 and followed for 12 months. The program comprised eight vascular surgeon-led group sessions, a digital platform, peer support groups, and smoking cessation counseling. Per-protocol analysis included 81 experimental and 78 control participants. Co-primary outcomes were health-related quality of life (SF-12) and peripheral artery disease -related hospitalization rate.

Results. At 12 months, the experimental group showed significantly higher SF-12 Physical Component Summary (44.76 vs. 35.08; p < 0.001) and Mental Component Summary (43.42 vs. 35.90; p < 0.001) scores. Hospitalizations (14.8 % vs. 20.5 %; p = 0.346) and amputations (4.9 % vs. 7.7 %; p = 0.476) were numerically lower but did not reach statistical significance. Smoking cessation was threefold higher (25.0 % vs. 8.5 %; p = 0.026), pain declined significantly (median VAS 3 vs. 5; p < 0.001), and QALYs were higher (0.67 vs. 0.60; p < 0.001). No adverse events attributable to the program were recorded.

Conclusions. The Chronic limb-threatening ischemia School significantly improved patient-reported outcomes and smoking cessation in patients with peripheral artery disease. Structured educational programs should be considered an integral component of comprehensive peripheral artery disease management.

1. Armstrong, E.J., Armstrong, D.G. (2021). Critical limb ischemia. Vasc Med, 26, 228–231. https://doi.org/10.1177/1358863X20987611

2. Khoury, S.R., Ratchford, E.V., Stewart, K.J. (2022). Supervised exercise therapy for patients with peripheral artery disease: Clinical update and pathways forward. Prog Cardiovasc Dis, 70, 183–189. https://doi.org/10.1016/j.pcad.2022.01.006

3. Norgren, L., Hiatt, W.R., Dormandy, J.A., et al. (2007). Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg, 45, S5–S67. https://doi.org/10.1016/j.jvs.2006.12.037

4. Davies, M.G. (2012). Critical Limb Ischemia: Epidemiology. Methodist Debakey Cardiovasc J, 8, 10. https://doi.org/10.14797/MDCJ-8-4-10

5. Wu, R., Yu, Y., Guo, J., et al. (2025). Risk Factors Affecting Quality of Life in Chronic Limb Threatening Ischemia Patients. Patient Prefer Adherence, 19, 1965–1972. https://doi.org/10.2147/PPA.S532224

6. Barshes, N.R., Chambers, J.D., Cohen, J., Belkin, M. (2012). Cost-effectiveness in the contemporary management of critical limb ischemia with tissue loss. J Vasc Surg, 56, 1015–1024. https://doi.org/10.1016/j.jvs.2012.02.069

7. Ormaechevarria, A., Vega de Ceniga, M., Blanco, J., et al. (2024). Critical Limb Ischaemia in Octogenarians: Treatment Outcomes Compared With Younger Patients. EJVES Vasc Forum, 61, 36. https://doi.org/10.1016/j.ejvsvf.2023.12.003

8. Muir, R.L. (2009). Peripheral arterial disease: Pathophysiology, risk factors, diagnosis, treatment, and prevention. J Vasc Nurs, 27, 26–30. https://doi.org/10.1016/j.jvn.2009.03.001

9. Armstrong, E.J., Wu, J., Singh, G.D., et al. (2014). Smoking cessation is associated with decreased mortality and improved amputation-free survival among patients with symptomatic peripheral artery disease. J Vasc Surg, 60, 1565–1571. https://doi.org/10.1016/j.jvs.2014.08.064

10. Wu, J.H., Wu, J.M., Huang, B., Wei, L.L. (2025). Exploring self-management's mediating role in health literacy and quality of life: evidence from COPD patients in Hunan, China. J Health Popul Nutr, 44. https://doi.org/10.1186/s41043-025-00812-7

11. Cui, X., Zhou, X., Ma, L., et al. (2019). A nurse-led structured education program improves self-management skills and reduces hospital readmissions in patients with chronic heart failure: a randomized and controlled trial in China. Rural Remote Health, 19. https://doi.org/10.22605/RRH5270

12. Bekele, B.B., Negash, S., Bogale, B., et al. (2020). The effectiveness of diabetes self-management education (DSME) on glycemic control among T2DM patients randomized control trial: systematic review and meta-analysis protocol. J Diabetes Metab Disord, 19, 1631. https://doi.org/10.1007/s40200-020-00584-3

13. Smolderen, K.G., Romain, G., Gosch, K., et al. (2023). Patient Knowledge and Preferences for Peripheral Artery Disease Treatment. Vasc Med, 28, 397. https://doi.org/10.1177/1358863X231181613

14. van Leeuwen, G.L., Kooijman, M.A., Schuurmann, R.C.L., et al. (2024). Health Literacy and Disease Knowledge of Patients With Peripheral Arterial Disease or Abdominal Aortic Aneurysm: A Scoping Review. Eur J Vasc Endovasc Surg, 67, 935–947. https://doi.org/10.1016/j.ejvs.2024.03.040

15. Abaraogu, U.O., Dall, P.M., Seenan, C.A. (2017). The Effect of Structured Patient Education on Physical Activity in Patients with Peripheral Arterial Disease and Intermittent Claudication: A Systematic Review. Eur J Vasc Endovasc Surg, 54, 58–68. https://doi.org/10.1016/j.ejvs.2017.04.003

16. Shkola kriticheskoj ishemii nizhnih konechnostej [School of Critical Limb Ischemia]. (2026). Retrieved February 8, 2026, from https://stepbystephealing.org/

17. Ware, J.E., Kosinski, M., Keller, S.D. (1996). A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care, 34, 220–233. https://doi.org/10.1097/00005650-199603000-00003

18. Delgado, D.A., Lambert, B.S., Boutris, N., et al. (2018). Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev, 2. https://doi.org/10.5435/JAAOSGLOBAL-D-17-00088

19. Brazier, J.E., Roberts, J. (2004). The estimation of a preference-based measure of health from the SF-12. Med Care, 42, 851–859. https://doi.org/10.1097/01.mlr.0000135827.18610.0d

20. Steinsbekk, A., Rygg, L., Lisulo, M., Rise, M.B., Fretheim, A. (2012). Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. BMC Health Serv Res, 12. https://doi.org/10.1186/1472-6963-12-213

21. Duff, S., Mafilios, M.S., Bhounsule, P., Hasegawa, J.T. (2019). The burden of critical limb ischemia: a review of recent literature. Vasc Health Risk Manag, 15, 187. https://doi.org/10.2147/VHRM.S209241

22. Behrooz, L., Abumoawad, A., Rizvi, S.H.M., Hamburg, N.M. (2023). A modern day perspective on smoking in peripheral artery disease. Front Cardiovasc Med, 10, 1154708. https://doi.org/10.3389/fcvm.2023.1154708

23. Streck, J.M., Rigotti, N.A., Livingstone-Banks, J., et al. (2024). Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev, 2024. https://doi.org/10.1002/14651858.CD001837.PUB4

24. Lane, R., Harwood, A., Watson, L., Leng, G.C. (2017). Exercise for intermittent claudication. Cochrane Database Syst Rev, 12. https://doi.org/10.1002/14651858.CD000990.PUB4

25. Murphy, T.P., Cutlip, D.E., Regensteiner, J.G., et al. (2012). Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: Six-month outcomes from the CLEVER study. Circulation, 125, 130–139. https://doi.org/10.1161/CIRCULATIONAHA.111.075770

26. Rochfort, A., Beirne, S., Doran, G., et al. (2018). Does patient self-management education of primary care professionals improve patient outcomes: a systematic review. BMC Fam Pract, 19. https://doi.org/10.1186/s12875-018-0847-x

27. Nusair, M.B., Khasawneh, R., Baali, F.H., et al. (2026). Patient Activation Among Individuals with Chronic Illness: A Cross-Sectional Study from Jordan. Healthcare, 14, 204. https://doi.org/10.3390/healthcare14020204

28. Chinaliyev, A., Saparbayev, S., Zhakiyev, B., et al. (2025). Allogeneic fibroblasts vs conventional debridement after successful endovascular interventions for treating chronic ulcers induced by peripheral artery disease. Wideochirurgia I Inne Tech Maloinwazyjne, 20, 226–234. https://doi.org/10.20452/wiitm.2025.17959

29. Barrios, V., Beato, P., Brotons, C., et al. (2022). Comprehensive management of risk factors in peripheral vascular disease. Expert consensus. Rev Clin Esp, 222, 82–90. https://doi.org/10.1016/j.rceng.2020.11.011

30. Alagna, M., Reilly, M.A., Iroz, C., et al. (2025). Patient perspectives on peripheral artery disease education and an online peripheral artery disease video education tool. JVS-Vascular Insights, 3. https://doi.org/10.1016/j.jvsvi.2025.100203