Status:

COMPLETED

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

Lead Sponsor:

Universidad Complutense de Madrid

Conditions:

Diabetic Foot

Orthopedic Disorder

Eligibility:

All Genders

18+ years

Phase:

NA

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...

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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 15 2022

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05353114

Start Date

June 15 2022

End Date

July 15 2022

Last Update

November 4 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, Spain, 28040