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

November 2, 2022 updated by: Jose Luis Lazaro Martinez, Universidad Complutense de Madrid

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Therapeutic Footwear prescription group
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
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).
The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements

What is the study measuring?

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.
Time Frame: 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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with an ulcer occurrence event
Time Frame: 1 month
Presence of a new o previous ulcer located in the foot in a patient with diabetes
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2022

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

July 15, 2022

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (ACTUAL)

April 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-042022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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