Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
Condition: Diabetes Mellitus, Type 2; Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

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).
    

Detailed description: 
      This clinical trial includes 2 parallel intervention groups with a pre- and post-test
      analysis. In the standard footwear (SF) group, plantar orthoses, standard footwear and
      education on foot self-care were applied and in the orthopedic footwear (OF) group the same
      intervention was applied, but with orthopedic footwear.

      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.
    

Intervention name(s): Orthopedic Footwear; Standard Footwear; Plantar Orthoses; Education on foot self-care
Intervention type(s): Device; Device; Device; Behavioral
Intervention description(s): 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A pre and post-test analysis was performed.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Quality of life; Postural Balance; Functionality; Foot Orthoses; Footwear