Clinical Study

Effects of a Short Educational Program for the Prevention of Foot Ulcers in High-Risk Patients: A Randomized Controlled Trial

Table 1

Baseline demographic and clinical characteristics of the patients enrolled.

Standard careEducational program

Number 6060
Gender (women, %)28 (46.7)20 (33.3)0.14
Age (years)69.4 ± 11.372.0 ± 8.90.11
Duration of diabetes (years)15.9 ± 11.214.2 ± 12.40.48
BMI (Kg/m2)30.0 ± 5.629.4 ± 4.70.61
Waist circumference (cm)106.4 ± 13.9104.2 ± 11.10.51
HbA1c (%)7.3 ± 1.47.4 ± 1.30.86
Systolic pressure (mmHg)139 ± 19136 ± 170.41
Diastolic pressure (mmHg)75 ± 1079 ± 160.24
Smokers/ex-smokers (%)20 (33.3)21 (35)0.59
Charlson’s comorbidity score2.9 ± 2.83.0 ± 2.70.87
PIN questionnaire score20 16; 2219 16; 200.65
Medical history (%)
 Peripheral artery disease 10 (16.7)5 (8.3)0.17
 Neuropathy48 (80.0)50 (83.3)0.89
 Previous ulcers6 (9.9)7 (11.7)0.49
 Foot abnormalities6 (9.9)3 (4.9)0.37
 Retinopathy 4 (6.7)10 (16.7)0.088
 Chronic renal failure6 (10.0)7 (11.7)0.77
 Cardiac disease18 (30.0)18 (30.0)>0.99
 Chronic heart failure 6 (10.0)5 (8.3)0.75
 Cerebrovascular disease††6 (10.0)4 (6.7)0.51
 Nonmetastatic malignancies 4 (6.7)5 (8.3)0.73
Treatment (%)
 Insulin 12 (20.0)17 (28.3)0.29
 Antihypertensive46 (76.7)50 (83.3)0.71
 Statin28 (46.7)25 (41.7)0.67
 Antiaggregant/coagulant50 (83.3)52 (86.7)0.78

In absence of neuropathy; data are expressed as number (%) and mean ± SD; previous myocardial infarction and/or angina pectoris; ††previous stroke or transient ischemic attack; creatinine >1.2 mg/dL.