NCT05353114

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Diabetic Foot
• Orthopedic Disorder
• Foot Ankle Injuries

Interventions

Type	Name	Description
OTHER	3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).	The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-06-30
• Completion: 2022-07-15
• First posted: 2022-04-29
• Last updated: 2022-11-04

Locations

1 site across 1 country: Spain