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Futility analysis suggested termination
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Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeated educational intervention | Experimental | Repetition every 6 months of a group educational session |
|
| Control group | Active Comparator | Initial single group educational session, with no repetition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeated intervention | Behavioral | Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of foot ulcers | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of foot ulcers | 6 months | |
| incidence of foot ulcers | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetologia AOU Careggi | Florence | 50134 | Italy |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Single session | Behavioral | Single 2-h group session educating patients at foot hygiene and ulcer prevention |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |