Clinical trial NCT04605900: Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
Official title: Impact of Therapeutic Footwear and Plantar Orthoses for Patients With Diabetic Neuropathic Foot in Quality of Life and Functionality: A Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetic Peripheral Neuropathy
Keywords: Quality of life
Postural Balance
Functionality
Foot Orthoses
Footwear
Lead sponsor: Universidade do Algarve
Sponsor class: OTHER
Collaborators: name: University of Huelva
name: OKM Química Ortopédica S.L.
name: Lola - J. Andrade Ferreira Neves Lda
name: Instituto São João de Deus (ISJD)
name: Ortobalance - Ortopedia Técnica e Desportiva
name: Sensor Médica
name: Pierre Fabre Portugal
name: Associação para o Estudo da Diabetes Mellitus e de Apoio ao Diabético do Algarve (AEDMADA)
name: Unidade Funcional de Faro - Agrupamento de Centros de Saúde do Central
First posted: 2020-10-28
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pre and post-test analysis was performed.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Presence of type 2 DM;
* Have at least 6 months from diagnosis of DM;
* Presence of Diabetic Polyneuropathy;
* No history of plantar orthoses and orthopedic footwear use.

Exclusion Criteria:

* Active ulceration;
* 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.

Primary outcomes:
measure: Change the Quality of Life
timeFrame: 4 months
measure: Change the Performance of Lower Extremity Functional Scale
timeFrame: 4 months
measure: Change the Functional Reach Test performance
timeFrame: 4 months
measure: Change the Unipedal Stance Test performance
timeFrame: 4 months
measure: Change the Static Full Tandem Test performance
timeFrame: 4 months
measure: Change the Walking Full Tandem Test performance
timeFrame: 4 months
measure: Change the Time Up and Go Test performance
timeFrame: 4 months
measure: Change the 6 minutes walk test performance
timeFrame: 4 months
Secondary outcomes:
measure: Change the Postural Stability (length displacement of Center of Pressure)
timeFrame: 4 months
measure: Change the Postural Stability (displacement of Center of Pressure)
timeFrame: 4 months
measure: Change the Postural Stability (Ellipse surface)
timeFrame: 4 months
measure: Change the Postural Stability (Mean Speed of Center of Pressure)
timeFrame: 4 months
measure: Change the Postural Stability (Standard deviation of Center of Pressure)
timeFrame: 4 months
measure: Change the Postural Stability (Root Mean Square)
timeFrame: 4 months
measure: Change the Postural Stability (Romberg Ration Index)
timeFrame: 4 months
measure: Change the mean pressure in static position
timeFrame: 4 months
measure: Change the maximum pressure in static position
timeFrame: 4 months
measure: Change the support surface in static position
timeFrame: 4 months
measure: Change the load distribution in static position
timeFrame: 4 months
measure: Change the maximum pressure in gait
timeFrame: 4 months
measure: Change the mean pressure in gait
timeFrame: 4 months
measure: Change the plantar impression length in gait
timeFrame: 4 months
measure: Change the support surface in gait
timeFrame: 4 months
measure: Change the longitude of CoP in gait
timeFrame: 4 months
measure: Change the load distribution in gait
timeFrame: 4 months
measure: Change the foot progression angle of gait
timeFrame: 4 months
measure: Change the double support time of gait
timeFrame: 4 months
measure: Change the support time of gait
timeFrame: 4 months
measure: Change the step length of gait
timeFrame: 4 months
measure: Adherence to the intervention
timeFrame: 2 months
measure: Self-Perception of improvements
timeFrame: 2 months
measure: Satisfaction with devices
timeFrame: 2 months
Other outcomes:
Locations:
city: Faro
country: Portugal
facility: Marta Botelho
state: Algarve
Study officials:
affiliation: Researcher
name: Marta Botelho, PhD
role: PRINCIPAL_INVESTIGATOR
References: