Evaluation of Rocker sOles in Diabetis

Diabetic Neuropathy Clinical Trial

— EROD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891928
• Other study ID #: ROCKER SOLE (RB 14.143)
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2016
• Last updated: September 1, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Intervention

Device:
• Rocker sole shoes
Measure of walk testing Measure of standing position
• Normal shoes
Measure of walk testing Measure of standing position

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inclusion	No