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Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear.
The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.
A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer.
After parallel randomization (1:1) patients will be enrolled into two different groups:
Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups.
Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapeutic Footwear prescription group | No Intervention | 1) Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences | |
| Therapeutic Footwear prescription based on a 3D Foot scanner | Experimental | 2) Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy). | Other | The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting. | Validation of proper therapeutic footwear fitting was performed by a specialized podiatrist after acquisition of shoes in both groups. TF was recommended to change when following ill fitting reason were found: excessive length or tight, or compromise with toes | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with an ulcer occurrence event | Presence of a new o previous ulcer located in the foot in a patient with diabetes | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universitaria de PodologÃa de la Universidad Complutense de Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 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 |