This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-10

Study Completion Date

2018-05-10

Brief Summary

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This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.

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Detailed Description

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Conditions

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Diabetic Foot Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Group

Rigid rocker sole footwear

Group Type EXPERIMENTAL

Rigid Rocker Sole Footwear

Intervention Type DEVICE

Control Group

Therapeutic footwear

Group Type ACTIVE_COMPARATOR

Therapeutic Footwear

Intervention Type DEVICE

Interventions

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Rigid Rocker Sole Footwear

Intervention Type DEVICE

Therapeutic Footwear

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
* Adult patients of both sexes.
* Peripheral neuropathy patients.
* Patients without wounds or ulcers at the examination time.
* Patients with a foot ulcers history.
* Patients with or without minor amputation prior to the inclusion time in the present study.
* Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.

Exclusion Criteria

* Patients with mayor amputation.
* Patients with rheumatic disease that affect the feet.
* Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
* Patients with several critical ischemia criteria, defined by TACS II guideline.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes