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

NCT05353114 | Completed

• 1 other identifier: CT-042022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Orthopedic Disorder; Foot Ankle Injuries

Keywords

Prevention; Therapeutic footwear; New technologies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with an ulcer occurrence event

  1 month

Study Arms (2)

Standard Therapeutic Footwear prescription group

NO INTERVENTION

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

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).

Interventions

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

The 3D foot scan becomes a movile app that recommends a specific size and model of therapeutic footwear according to the measurements

Therapeutic Footwear prescription based on a 3D Foot scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3).
• Capability to walk autonomously without walking aids.
• Diabetic Peripheral neuropathy.

You may not qualify if:

• Major amputation in the contralateral limb (below or above the knee).

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Diabetic Foot; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 29, 2022
• Study Start: June 15, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 15, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)