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

Diabetic Foot Clinical Trial

— Smartfitting  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353114
• Other study ID #: CT-042022
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: November 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ankle Injuries
• Diabetic Foot
• Foot Ankle Injuries
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Universitaria de Podología de la Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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