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Evaluation of Rocker sOles in Diabetis (EROD)

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Rocker sole shoes
Normal shoes
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, "Rocker sole" shoes, Walking

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU de Brest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

with rocker sole

without rocker sole

Arm Description

patient were wearing the rocker soles shoes during investigation

patient were wearing normal shoes during investigation

Outcomes

Primary Outcome Measures

Anteroposterior displacement amount of the center of pressure with regard to the center of mass.
Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform

Secondary Outcome Measures

Full Information

First Posted
August 26, 2016
Last Updated
September 1, 2016
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02891928
Brief Title
Evaluation of Rocker sOles in Diabetis
Acronym
EROD
Official Title
Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, "Rocker sole" shoes, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with rocker sole
Arm Type
Experimental
Arm Description
patient were wearing the rocker soles shoes during investigation
Arm Title
without rocker sole
Arm Type
Placebo Comparator
Arm Description
patient were wearing normal shoes during investigation
Intervention Type
Device
Intervention Name(s)
Rocker sole shoes
Intervention Description
Measure of walk testing Measure of standing position
Intervention Type
Device
Intervention Name(s)
Normal shoes
Intervention Description
Measure of walk testing Measure of standing position
Primary Outcome Measure Information:
Title
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.
Description
Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform
Time Frame
Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Remy-Neris, Professor
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data are not planned to be shared

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Evaluation of Rocker sOles in Diabetis

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