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OpenTrials
Completed

NCT Number: NCT05353114

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ankle Injuries Foot Ulcer Leg Ulcer Musculoskeletal Diseases Orthopedic Disorder Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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:

  • Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study 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.

Acronym: Smartfitting

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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