Clinical Efficacy of a 3D Foot Scanner for the Therapeutic Footwear Fitting

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences; 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). 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

Official Title
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Clinical Efficacy of a 3D Foot Scanner App for the Fitting of Therapeutic Footwear in Persons With Diabetes in Remission: A Randomized and Controlled Clinical Trial.

Conditions
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Diabetic Foot, Orthopedic Disorder, Foot Ankle Injuries

Intervention / Treatment
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* Other: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3). Healed diabetic foot ulcer at the moment of inclusion. Capability to walk autonomously without walking aids. Diabetic Peripheral neuropathy. Exclusion Criteria: Major amputation in the contralateral limb (below or above the knee).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Therapeutic Footwear prescription group<br>1) Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences | |
| Experimental: Therapeutic Footwear prescription based on a 3D Foot scanner<br>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). | Other: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).<br>* The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Therapeutic footwear, New technologies