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

Universidad Complutense de Madrid

Status: Completed

Conditions: Foot Ankle Injuries; Orthopedic Disorder; Diabetic Foot

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05353114

CT-042022

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard Therapeutic Footwear prescription group

No Intervention group

Description:

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 group

Description:

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).

Treatment:

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