Several studies, including some randomized controlled trials [
Group educational programs could theoretically be more cost-effective than individual patient education. In a randomized trial, a 1-hour group educational program reduced the incidence of amputation and new ulcerations in diabetic patients with foot infection, ulceration, or prior amputation referred for podiatry or vascular surgery [
Considering that available resources are limited, brief and inexpensive educational programs have a greater chance of being applied in routine clinical practice. Although longer and more intensive educational programs were reported to be more effective than brief interventions for foot ulcer prevention [
The aim of the present study is to assess the feasibility and efficacy of a brief educational program for the prevention of diabetic foot ulcers in high-risk patients referring to a diabetes outpatient clinic.
This study, designed as a randomized, open-label, single-center clinical trial, with a 6-month follow-up, was approved by the local Ethical Committee. The study was performed on outpatients aged ≥18 years, affected by type 2 diabetes, who fulfilled at least one of the following three criteria (for definition of high risk of foot ulcers): diagnosis of neuropathy, previous diabetic foot ulcer, or foot abnormalities at risk for ulcer in the opinion of the investigator. Patients with peripheral vascular disease requiring immediate revascularization, as well as those with cognitive impairment, were excluded. All patients had previously received standard multidisciplinary education for diabetes (with a structured group program at diagnosis or first contact, and follow-up meetings every two years), but no educational intervention specifically focused on foot care. After providing written informed consent, patients were randomized in a 1 : 1 ratio either to intervention or to control group. The randomization procedure was based on a computer-generated list held by an independent randomization center (Diabetes Agency) that was contacted by telephone each time a person was randomized. The principal endpoint was the incidence of foot ulcers.
The intervention was a two-hour program provided to groups of 5–7 patients (mean:
At randomization, the PIN (Patient Interpretation of Neuropathy) questionnaire was administered to the patients, exploring patients’ knowledge about signs and symptoms of neuropathy and risk factors for foot ulcers onset [
Follow-up visits were planned at 3 and 6 months from randomization, for foot examination. Patients who did not show up at control visits were actively contacted through telephone calls. In patients who developed ulcers, the number of visits at the foot clinic (performed either by physician or by nurse) was recovered from administrative databases of hospital activity; physicians’ and nurses’ visits are scheduled every 30 and 20 minutes, respectively.
The power calculation, based on the incidence of ulcers observed in previous studies [
For statistical analysis, continuous variables (expressed as mean ± SD or as median [quartiles]) were compared between groups with unpaired Student’s
The study was prematurely terminated due to a highly significant difference in outcome between the two treatment groups. The final sample was therefore composed of 121 patients. One patient (in the intervention group) was lost at follow-up and was therefore excluded from the analysis. The baseline characteristics of the final sample are summarized in Table
Baseline demographic and clinical characteristics of the patients enrolled.
Standard care | Educational program |
| |
---|---|---|---|
Number | 60 | 60 | — |
Gender (women, %) | 28 (46.7) | 20 (33.3) | 0.14 |
Age (years) | 69.4 ± 11.3 | 72.0 ± 8.9 | 0.11 |
Duration of diabetes (years) | 15.9 ± 11.2 | 14.2 ± 12.4 | 0.48 |
BMI (Kg/m2) | 30.0 ± 5.6 | 29.4 ± 4.7 | 0.61 |
Waist circumference (cm) | 106.4 ± 13.9 | 104.2 ± 11.1 | 0.51 |
HbA1c (%) | 7.3 ± 1.4 | 7.4 ± 1.3 | 0.86 |
Systolic pressure (mmHg) | 139 ± 19 | 136 ± 17 | 0.41 |
Diastolic pressure (mmHg) | 75 ± 10 | 79 ± 16 | 0.24 |
Smokers/ex-smokers (%) | 20 (33.3) | 21 (35) | 0.59 |
Charlson’s comorbidity score | 2.9 ± 2.8 | 3.0 ± 2.7 | 0.87 |
|
20 |
19 |
0.65 |
Medical history (%) | |||
Peripheral artery disease | 10 (16.7) | 5 (8.3) | 0.17 |
Neuropathy | 48 (80.0) | 50 (83.3) | 0.89 |
Previous ulcers | 6 (9.9) | 7 (11.7) | 0.49 |
Foot abnormalities |
6 (9.9) | 3 (4.9) | 0.37 |
Retinopathy | 4 (6.7) | 10 (16.7) | 0.088 |
Chronic renal failure‡ | 6 (10.0) | 7 (11.7) | 0.77 |
Cardiac disease† | 18 (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 |
Antihypertensive | 46 (76.7) | 50 (83.3) | 0.71 |
Statin | 28 (46.7) | 25 (41.7) | 0.67 |
Antiaggregant/coagulant | 50 (83.3) | 52 (86.7) | 0.78 |
Selected clinical parameters at 6-month follow-up.
Standard care | Educational program |
| |
---|---|---|---|
Number | 60 | 60 | — |
BMI (Kg/m2) | 30.1 ± 5.7 | 29.5 ± 4.6 | 0.29 |
HbA1c (%) | 7.3 ± 1.4 | 7.1 ± 1.2 | 0.37 |
Systolic pressure (mmHg) | 136 ± 15 | 137 ± 18 | 0.62 |
Diastolic pressure (mmHg) | 77 ± 11 | 78 ± 16 | 0.65 |
Data are expressed as number (%) and mean ± SD.
No amputation was reported in the sample enrolled. Two patients died during follow-up (one in the standard care and one in the interventional group); none of them had developed ulcers, and they were included in the analysis until death. Six patients, all in the control group, developed ulcers during the 6-month follow-up (10% versus 0%,
Kaplan-Meier survival curves (patients free of event) for incidence of foot ulcers in intervention (grey line) and control (black line) groups.
Time spent for intervention was 150 and 1050 minutes (2.5 and 17.5 minutes per patient) for physician and nurse, respectively, whereas time spent for ulcer care in the control group was 390 and 1200 minutes (6.5 and 20 minutes for each patient randomized to control).
A brief, 2-hour, focused group educational program is effective in preventing diabetic foot ulcers in high-risk patients, as previously reported in another study [
Some limitations of the present study should be recognized. This is a single-center trial, performed by highly trained health professionals working in a diabetic foot clinic; the reproducibility of this program in a different setting should be verified. The cost of drugs and materials used for the treatment of ulcers was not assessed, leading to an underestimation of the direct costs in the control group. Although patients’ knowledge was improved by the intervention, no data were collected on patients’ skills or actual behaviors during follow-up. In addition, the therapeutic effects of patient education tend to fade with time [
Despite these limitations, the proposed intervention appears to provide a sustainable and effective approach to targeted education for diabetic foot ulcer prevention.
The educational program was composed of two sections.
Patients were instructed on how to check regularly their feet (using a mirror or asking for someone else’s help), looking for possible lesions. The following information was also provided: Ulcers: minor scrapes or cuts that heal slowly, or sores from unfit shoes, can become infected, causing ulcers. Dry skin: patients were advised to use moisturizing soaps and hydrating lotions/oils, without using them between toes. Blisters: they can be a sign of unfit shoes, and they should not be opened (for the risk of infection). Corns/calluses: they should be gently removed with an emery board or pumice stone, without using any kind of blade. Ingrown toenails: toenails must be trimmed regularly. Discolored/yellowed toenails: they are a possible sign of a fungal nail infection. Redness, warmth, swelling, or pain: they are possible symptoms of inflammation and infection; medical advice should be immediately sought in this case. Blue or black skin color: they are possible symptoms of critical ischemia, needing immediate medical contact.
At the end of this formal lesson, patients were allowed to participate in an interactive discussion.
Footbath: one patient was asked to prepare an adequate (in his/her opinion) foot bath and to wash his/her feet. Based on the performance of the patient, the whole group was asked to discuss the procedure. The aim of this exercise was the acquisition of the following rules: Use of warm water. Choice of mild soaps. Accurate drying of feet, including interdigital areas. Using a pen, patients were asked to trace the outline of their entire foot on a sheet of paper and to put it inside the shoe they wore. The aim of this exercise was that of focusing the patients’ attention on the need for fit and comfortable shoes. The choice of shoes was then discussed with the whole group.
Matteo Monami has received speaking fees from Astra, Boehringer, Bristol Myers Squibb, Eli-Lilly, Merck, Novartis, Novonordisk, Sanofi, and Takeda and research grants from Bristol Myers Squibb. Stefania Zannoni, Marianna Gaias, and Besmir Nreu have no conflict of interests. Niccolò Marchionni has received speaking fees from Boehringer, Bristol Myers Squibb, Eli-Lilly, Merck, Novartis, and Novonordisk. Edoardo Mannucci has received consultancy fees from Merck and Novartis, speaking fees from Astra Zeneca, Bristol Myers Squibb, Merck, and Novartis, and research grants from Merck, Novartis, and Takeda.
Matteo Monami was involved in each of the following points: (1) design, (2) data collection, (3) analysis, and (4) writing of the paper. Stefania Zannoni was involved in each of the following points: (1) data collection, (2) analysis, and (3) writing of the paper. Marianna Gaias was involved in each of the following points: (1) data collection and (2) analysis. Besmir Nreu was involved in each of the following points: (1) data collection, (2) analysis, and (3) writing of the paper. Niccolò Marchionni was involved in each of the following points: (1) design and (2) writing of the paper. Edoardo Mannucci was involved in each of the following points: (1) design, (2) data collection, (3) analysis, and (4) writing of the paper. All the authors approved the final version of this paper.
The authors would like to thank Domenica Catalano, Angela Becheri, Fabiana Fabbri, Elisabetta Nardini, Donatella Renna, and Rosanna Boni, Division of Geriatric Cardiology and Medicine, Careggi Teaching Hospital.