Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality

Summary

This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies.

The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).

Conditions

• Diabetes Mellitus, Type 2
• Diabetic Peripheral Neuropathy

Interventions

DEVICE

Orthopedic Footwear

The orthopedic footwear used by the OF Group was manufactured by the company J. Andrade Ferreira Neves Lda. with materials suitable for the diabetic foot, as registered with INFARMED under registration ID 279515.

DEVICE

Standard Footwear

In the SF Group, it was recommended to use standard shoes more suitable for diabetic foot, with some specific characteristics, such as sports or walking shoes. The acquisition or not of a more suitable shoes by the participants was at the discretion of each individual.

DEVICE

Plantar Orthoses

The plantar orthoses (PO) that both groups used for distribute of plantar loads was based on the principle of total contact. The confection material consisted in a liner of EVA shore 20º and polyurethane filling ELAX flexible (expandable) from OKM Química Ortopédica SL.

BEHAVIORAL

Education on foot self-care

An information leaflet with foot care was delivered, with the aim of ensuring that participants were informed about the care they should continually take with their feet during the study period. This leaflet was created based on the guidelines of the "Associação Protetora dos Diabéticos" in Portugal.

Sponsors & Collaborators

• University of Huelva

  collaborator OTHER

• OKM Química Ortopédica S.L.

  collaborator UNKNOWN

• Lola - J. Andrade Ferreira Neves Lda

  collaborator UNKNOWN

• Instituto São João de Deus (ISJD)

  collaborator UNKNOWN

• Ortobalance - Ortopedia Técnica e Desportiva

  collaborator UNKNOWN

• Sensor Médica

  collaborator UNKNOWN

• Pierre Fabre Portugal

  collaborator UNKNOWN

• Associação para o Estudo da Diabetes Mellitus e de Apoio ao Diabético do Algarve (AEDMADA)

  collaborator UNKNOWN

• Unidade Funcional de Faro - Agrupamento de Centros de Saúde do Central

  collaborator UNKNOWN

• Universidade do Algarve

  lead OTHER

Principal Investigators

• Marta Botelho, PhD · Researcher

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-13

Primary Completion

2018-01-04

Completion

2018-05-21

Countries

• Portugal

Study Locations