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

Universidad Complutense de Madrid

Status: Completed

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Treatments: Device: Therapeutic Footwear; Device: Rigid Rocker Sole Footwear

Study type: Interventional

Funder types: Other

Identifiers

NCT02995863

UComplutenseMadrid

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Rigid rocker sole footwear

Treatment:

Device: Rigid Rocker Sole Footwear

Control Group

Active Comparator group

Description:

Therapeutic footwear

Treatment:

Device: Therapeutic Footwear