Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
NCT ID: NCT04605900
Last Updated: 2020-10-30
Study Results
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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COMPLETED
NA
43 participants
INTERVENTIONAL
2017-03-13
2018-05-21
Brief Summary
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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).
Detailed Description
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Both intervention groups were evaluated at two different time points, with the pre-test taking place at the beginning of the study (T0 - Baseline) and the post-test taking place 4 months after the application of the treatment (T4). In the middle of the study, at two months (T2) a questionnaire was applied in order to understand the adherence and the perception of individuals about the intervention applied.
The screening of diabetic peripheral neuropathy was made with the Michigan Neuropathy Screening Instrument (MNSI) and the description of the sample with an evaluation questionnaire.
The FL was evaluated through the Lower Extremity Functional Scale (LEFS), physical tests and the postural, static and dynamic barometric assessment. QoL was assessed with SF-36 and the adherence and satisfaction with a questionnaire created ad hoc.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Footwear (SF)
Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear.
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.
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.
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.
Orthopedic Footwear (OF)
Intervention: plantar orthoses, education on foot self-care and orthopedic footwear.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Have at least 6 months from diagnosis of DM;
* Presence of Diabetic Polyneuropathy;
* No history of plantar orthoses and orthopedic footwear use.
Exclusion Criteria
* Severe osteoarticular deformities;
* Presence of cognitive impairment;
* Gait with technical devices;
* Diagnosis of neurological pathology that can affect the gait pattern;
* Diagnosis of another pathology that can negatively influence the study: depression, the presence of uncontrolled cardiovascular diseases and active cancer.
* Surgical interventions on the spine and lower limbs, with less than 1 year of recovery.
40 Years
80 Years
ALL
No
Sponsors
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University of Huelva
OTHER
OKM Química Ortopédica S.L.
UNKNOWN
Lola - J. Andrade Ferreira Neves Lda
UNKNOWN
Instituto São João de Deus (ISJD)
UNKNOWN
Ortobalance - Ortopedia Técnica e Desportiva
UNKNOWN
Sensor Médica
UNKNOWN
Pierre Fabre Portugal
UNKNOWN
Associação para o Estudo da Diabetes Mellitus e de Apoio ao Diabético do Algarve (AEDMADA)
UNKNOWN
Unidade Funcional de Faro - Agrupamento de Centros de Saúde do Central
UNKNOWN
Universidade do Algarve
OTHER
Responsible Party
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Marta Botelho
Research Fellowship
Principal Investigators
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Marta Botelho, PhD
Role: PRINCIPAL_INVESTIGATOR
Researcher
Locations
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Marta Botelho
Faro, Algarve, Portugal
Countries
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Other Identifiers
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0348_CIE_6_E
Identifier Type: -
Identifier Source: org_study_id