Evaluation of Rocker sOles in Diabetis (EROD)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathy

Treatments: Device: Rocker sole shoes; Device: Normal shoes

Study type: Interventional

Funder types: Other

Identifiers

NCT02891928

ROCKER SOLE (RB 14.143)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

with rocker sole

Experimental group

Description:

patient were wearing the rocker soles shoes during investigation

Treatment:

Device: Rocker sole shoes

without rocker sole

Placebo Comparator group

Description:

patient were wearing normal shoes during investigation

Treatment:

Device: Normal shoes