Long-Term Effect of a Structured Educational Program on Diabetic Foot on Major Adverse Limb and Cardiovascular Events in People with Type 1 Diabetes
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design and Population
2.2. Intervention
2.3. Routine Diabetes Management and Follow-Up
2.4. Primary Outcomes
2.5. Covariates
2.6. Physical Examination
2.7. Statistical Analysis
3. Results
3.1. Participant Characteristics
3.2. Structured Diabetic Foot Education Program
3.3. Events During the Follow-Up
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
| CKD-EPI | Chronic Kidney Disease–Epidemiology Collaboration DFU: diabetic-related foot ulcer |
| DFU | Diabetic kidney disease |
| DKD | Diabetic kidney disease |
| DSMES | Diabetes self-management education and support |
| eGFR | Estimated glomerular filtration rate |
| EPs | Educational programs |
| LOPS | Loss of protective sensation |
| MACE | Major adverse cardiovascular event |
| MALE | Major adverse limb event |
| RCTs | Randomized controlled trials |
| PAD | Peripheral arterial disease |
| STROBE | Strengthening the Reporting of Observational Studies in Epidemiology |
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| N = 327 | |||
|---|---|---|---|
| Demographic characteristics | Age (years) | 42.5 13.7 | |
| Sex (female) | 164 (50.2) | ||
| Higher education | 30/276 (10.9) | ||
| European descendent | 327 (100) | ||
| Active smoking habit | 91/307 (29.7) | ||
| Diabetes duration (years) | 14 (8–22) | ||
| Comorbidities and cardioprotective drugs | |||
| Hypertension | 48/306 (15.7) | ||
| Dyslipidemia | 59/280 (21.1) | ||
| Use of antiplatelets | 21/288 (7.3) | ||
| Diabetes-related complications | |||
| Retinopathy | 91/233 (39.1) | ||
| DKD | 16/112 (14.3) | ||
| Neuropathy | 39/285 (13.7) | ||
| Myocardial infarction | 10/278 (3.6) | ||
| Stroke | 3/273 (1.1) | ||
| Foot complications history | |||
| Major amputation (above the forefoot) | 0/295 | ||
| Minor amputation (below the forefoot) | 4/295 (1.4) | ||
| Loss of protective sensation | 30/299 (10.0) | ||
| Peripheral artery disease | 50/312 (16.0) | ||
| Physical examination | Body mass index | N | 286 |
| Kg/m2 | 26.0 17.3 | ||
| Systolic blood pressure (mmHg) | 130 19 | ||
| Diastolic blood pressure (mmHg) | 76 13 | ||
| Foot lesions | |||
| Hammertoes | 5/280 (1.7) | ||
| Bunions | 9/299 (3.0) | ||
| Callus | 33/299 (11.0) | ||
| Diabetic foot ulcers | 7/296 (2.4) | ||
| Skin lesions | 31/293 (10.6) | ||
| Nail lesions | 21/292 (7.2) | ||
| Laboratory measures | HbA1c | N | 283 |
| % | 7.9 (6.9–9.1) | ||
| mmol/mol | 62.8 (51.9–76.0) | ||
| Total cholesterol | N | 270 | |
| mg/dL | 187 (165–213) | ||
| Triglycerides | N | 264 | |
| mg/dL | 87 (64–123.5) | ||
| HDL-cholesterol | N | 191 | |
| mg/dL | 51 (42–63) | ||
| LDL-cholesterol | N | 190 | |
| mg/dL | 114.2 (97–139.6) | ||
| Serum creatinine | N | 151 | |
| mg/dL | 0.98 (0.9–1.1) | ||
| eGFR(CKD-EPI) | N | 151 | |
| mL/min/1.73 m2 | 91 (78.9–101) | ||
| 1 EP (n = 157) | 2–3 EP (n = 94) | >3 EP (n = 76) | p | ||
|---|---|---|---|---|---|
| Demographic characteristics | |||||
| Age (years) | 44.9 14.6 | 41.1 13.1 † | 39.3 11.5 † | 0.007 | |
| Sex (female) | 69 (44.2) | 47 (50) | 47 (61.8) | 0.042 | |
| Higher education | 9/116 (7.8) | 11/88 (12.5) | 10/72 (13.9) | 0.354 | |
| Active smoking habit | 46/142 (32.4) | 28/92 (30.4) | 17/73 (23.3) | 0.376 | |
| Diabetes duration (years) | 13 (7–22) | 13.5 (9–24) | 15 (8.5–23) | 0.619 | |
| Comorbidities and cardioprotective treatment | |||||
| Hypertension | 32/141 (22.7) | 10/90 (11.1) | 7/75 (9.3) † | 0.012 | |
| Dyslipidemia | 40/118 (33.9) | 18/88 (20.5) | 1/74 (1.35) †, ‡ | <0.001 | |
| Use of antiplatelets | 15/130 (11.5) | 5/84 (6.0) | 1/74 (1.4) † | 0.023 | |
| Diabetes-related complications | |||||
| Retinopathy | 37/109 (33.9) | 33/74 (44.6) | 21/50 (42.0) | 0.312 | |
| DKD | 5/56 (8.9) | 3/25 (12.0) | 8/31 (25.8) | 0.092 | |
| Neuropathy | 17/134 (12.7) | 13/86 (15.1) | 9/65 (13.9) | 0.876 | |
| Myocardial infarction | 4/133 (3.0) | 3/81 (3.7) | 3/64 (4.7) | 0.786 | |
| Stroke | 2/131 (1.5) | 1/81 (1.2) | 0 | 0.769 | |
| Foot complications history | |||||
| Major amputation (above the forefoot) | 0 | 0 | 0 | - | |
| Minor amputation (below the forefoot) | 2/144 (1.4) | 1/87 (1.2) | 1/64 (1.6) | 0.976 | |
| Loss of protective sensation | 16/147 (12.9) | 7/85 (8.2) | 4/67 (6.0) | 0.236 | |
| Peripheral artery disease | 23/151 (15.2) | 13/90 (14.4) | 14/71 (19.7) | 0.620 | |
| Physical examination | |||||
| Body mass index | N | 122 | 91 | 73 | |
| Kg/m2 | 27.5 26.2 | 25.0 3.8 | 24.8 3.8 | 0.449 | |
| Systolic blood pressure (mmHg) | 129 18 | 130 19 | 132 18 | 0.493 | |
| Diastolic blood pressure (mmHg) | 75 10 | 76 13 | 78 15 | 0.283 | |
| Foot lesions | |||||
| Hammertoes | 2/130 (1.5) | 3/83 (3.6) | 0 | 0.241 | |
| Bunions | 2/145 (1.4) | 5/87 (5.8) | 2/67 (3.0) | 0.169 | |
| Callus | 13/145 (9.0) | 12/87 (13.8) | 8/67 (11.9) | 0.506 | |
| Diabetic foot ulcers | 2/144 (1.4) | 2/87 (2.3) | 3/65 (4.6) | 0.364 | |
| Skin lesions | 9/143 (6.3) | 12/86 (14.0) | 10/64 (15.6) | 0.063 | |
| Nail lesions | 12/142 (8.5) | 3/87 (3.5) | 6/63 (9.5) | 0.262 | |
| Laboratory measures | |||||
| HbA1c | N | 134 | 80 | 69 | 0.057 |
| % | 8.1 (7.3–9.3) | 7.8 (6.6–8.8) | 7.6 (6.5–8.9) | ||
| mmol/mol | 65.0 (56.3–78.1) | 61.7 (48.6–72.1) | 59.6 (47.5–73.8) | ||
| Total cholesterol | N | 123 | 74 | 73 | 0.556 |
| mg/dL | 186 (158–213) | 184 (165–225) | 191 (174–207) | ||
| Triglycerides | N | 120 | 73 | 71 | 0.014 |
| mg/dL | 84.5 (70.5–129.5) | 79 (61–108) | 83 (63–101) † | ||
| Cholesterol-HDL | N | 88 | 50 | 53 | 0.137 |
| mg/dL | 47.5 (40–61) | 55.5 (44–68) | 52 (44–64) | ||
| Cholesterol-LDL | N | 87 | 50 | 53 | 0.582 |
| mg/dL | 114.2 (94.8–135.6) | 115.7 (87.4–148.4) | 112.8 (105–140.2) | ||
| Serum creatinine | N | 71 | 37 | 43 | 0.734 |
| mg/dL | 0.92 (0.9–1.1) | 1 (0.9–1.1) | 1 (0.9–1.1) | ||
| eGFR(CKD-EPI) | N | 71 | 37 | 43 | 0.9201 |
| mL/min/1.73 m2 | 93.2 (77.0–105.3) | 91.9 (80.5–100.7) | 90.0 (82.0–96.7) | ||
| Outcome | EP | n/N (%) | Crude Model HR (95% CI) | Adjusted Model 1 HR (95% CI) | Adjusted Model 2 HR (95% CI) | Adjusted Model 3 HR (95% CI) |
|---|---|---|---|---|---|---|
| First MACE | 1 | 49/157 (31.2) | 1 (reference) | 1 (reference) | 1 (reference) | 1 (reference) |
| 2–3 | 28/94 (29.8) | 0.67 (0.41–1.07) | 1.21 (0.73–2.01) | 1.02 (0.58–1.82) | 1.10 (0.60–2.03) | |
| >3 | 16/76 (21.1) | 0.31 (0.18–0.56) * | 0.56 (0.30–1.03) | 0.48 (0.24–0.99) * | 0.56 (0.27–1.17) | |
| Components of MACE: | ||||||
| Non-fatal stroke | 1 | 4/141 (2.8) | 1 (reference) | 1 (reference) | 1 (reference) | 1 (reference) |
| 2–3 | 3/88 (3.4) | 1.09 (0.24–4.88) | 1.46 (0.31–6.90) | 1.45 (0.17–14.41) | 1.49 (0.17–13.04) | |
| >3 | 2/73 (2.7) | 0.80 (0.14–4.37) | 1.12 (0.19–6.77) | 1.75 (0.17–17.57) | 2.26 (0.20–25.55) | |
| Non-fatal myocardial infarction | 1 | 6/141 (4.3) | 1 (reference) | 1 (reference) | 1 (reference) | 1 (reference) |
| 2–3 | 6/89 (6.7) | 1.31 (0.42–4.09) | 1.55 (0.48–4.96) | 0.83 (0.23–2.87) | 0.75 (0.21–2.62) | |
| >3 | 6/73 (8.2) | 1.27 (0.40–4.03) | 1.56 (0.47–5.21) | 0.88 (0.27–2.97) | 0.84 (0.24–2.85) | |
| Death from any cause | 1 | 44/157 (28.0) | 1 (reference) | 1 (reference) | 1 (reference) | 1 (reference) |
| 2–3 | 24/93 (25.8) | 0.59 (0.36–0.98) * | 1.06 (0.62–1.80) | 0.95 (0.50–1.80) | 1.04 (0.54–2.02) | |
| >3 | 12/76 (15.8) | 0.24 (0.12–0.46) * | 0.45 (0.22–0.89) * | 0.36 (0.16–0.83) * | 0.44 (0.19–1.02) |
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Alonso-Carril, N.; Valverde, M.; Anglada, J.; García-Pascual, L.; Barahona, M.-J.; Rodríguez-Rodríguez, S.; Berrocal, B.; Quirós, C.; Simó-Servat, A.; Puig-Jové, C.; et al. Long-Term Effect of a Structured Educational Program on Diabetic Foot on Major Adverse Limb and Cardiovascular Events in People with Type 1 Diabetes. J. Clin. Med. 2025, 14, 8149. https://doi.org/10.3390/jcm14228149
Alonso-Carril N, Valverde M, Anglada J, García-Pascual L, Barahona M-J, Rodríguez-Rodríguez S, Berrocal B, Quirós C, Simó-Servat A, Puig-Jové C, et al. Long-Term Effect of a Structured Educational Program on Diabetic Foot on Major Adverse Limb and Cardiovascular Events in People with Type 1 Diabetes. Journal of Clinical Medicine. 2025; 14(22):8149. https://doi.org/10.3390/jcm14228149
Chicago/Turabian StyleAlonso-Carril, Núria, Maite Valverde, Jordi Anglada, Luis García-Pascual, Maria-José Barahona, Silvia Rodríguez-Rodríguez, Belén Berrocal, Carmen Quirós, Andreu Simó-Servat, Carlos Puig-Jové, and et al. 2025. "Long-Term Effect of a Structured Educational Program on Diabetic Foot on Major Adverse Limb and Cardiovascular Events in People with Type 1 Diabetes" Journal of Clinical Medicine 14, no. 22: 8149. https://doi.org/10.3390/jcm14228149
APA StyleAlonso-Carril, N., Valverde, M., Anglada, J., García-Pascual, L., Barahona, M.-J., Rodríguez-Rodríguez, S., Berrocal, B., Quirós, C., Simó-Servat, A., Puig-Jové, C., Martínez, D., Ferré, C., Amor, A. J., & Perea, V. (2025). Long-Term Effect of a Structured Educational Program on Diabetic Foot on Major Adverse Limb and Cardiovascular Events in People with Type 1 Diabetes. Journal of Clinical Medicine, 14(22), 8149. https://doi.org/10.3390/jcm14228149

