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

Not Applicable

Completed

• Conditions: Diabetic Foot; Foot Ankle Injuries; Orthopedic Disorder
• Interventions: Other: 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).

• Registration Number: NCT05353114
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-04-29
• Study Start: 2022-06-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Footwear prescription based on a 3D Foot scanner	3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).	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).

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was the requirement of Therapeutic Footwear change after prescription because ill fitting.	1 week	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with an ulcer occurrence event	1 month	Presence of a new o previous ulcer located in the foot in a patient with diabetes

Trial Locations

Locations (1)

Clínica Universitaria de Podología de la Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain