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

NACompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 13, 2017

Primary Completion Date

January 4, 2018

Study Completion Date

May 21, 2018

Conditions
Diabetes Mellitus, Type 2Diabetic 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."

Trial Locations (1)

8005-139

Marta Botelho, Faro

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Huelva

OTHER

collaborator

OKM Química Ortopédica S.L.

UNKNOWN

collaborator

Lola - J. Andrade Ferreira Neves Lda

UNKNOWN

collaborator

Instituto São João de Deus (ISJD)

UNKNOWN

collaborator

Ortobalance - Ortopedia Técnica e Desportiva

UNKNOWN

collaborator

Sensor Médica

UNKNOWN

collaborator

Pierre Fabre Portugal

UNKNOWN

collaborator

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

UNKNOWN

collaborator

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

UNKNOWN

lead

Universidade do Algarve

OTHER

NCT04605900 - Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality | Biotech Hunter | Biotech Hunter