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Completed

NCT Number: NCT02891928

Evaluation of Rocker sOles in Diabetis

The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

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Key information

About this study

Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with Type 2 Diabetes
  • Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
  • Can walk without technical assistance
  • Age from 18 to 75
  • Having made his non-opposition

Exclusion criteria

  • Presence of ulceration of the foot (or a history of this type)
  • History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.

Treatment and study plan

Rocker sole shoes

Device

Measure of walk testing Measure of standing position

Normal shoes

Device

Measure of walk testing Measure of standing position

Primary outcomes

  1. Anteroposterior displacement amount of the center of pressure with regard to the center of mass.

    Time frame: Inclusion

    Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy

Acronym: EROD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2016
Registry last updated
Dec 3, 2025

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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