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

Impact of Therapeutic Footwear and Plantar Orthoses for Patients With Diabetic Neuropathic Foot in Quality of Life and Functionality: A Interventional Study

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: Standard Footwear; Device: Plantar Orthoses; Behavioral: Education on foot self-care; Device: Orthopedic Footwear

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Algarve
    • Faro, Algarve, Portugal, 8005-139
      • Marta Botelho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standard Footwear (SF); Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear.	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.
EXPERIMENTAL: Orthopedic Footwear (OF); Intervention: plantar orthoses, education on foot self-care and orthopedic footwear.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the Quality of Life	Significantly change any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey instrument, that was use it to assess quality of life. Instrument scores can range between 0 - 100. Higher values mean better self-perception of quality of life.	4 months
Change the Performance of Lower Extremity Functional Scale	Change at least 9 points in Lower Extremity Functional Scale (minimum change for clinically relevant functional improvement). Instrument scores can range between 0 - 80. Higher values mean better functionality.	4 months
Change the Functional Reach Test performance	Significantly change the maximum distance (cm) attained in Functional Reach Test.	4 months
Change the Unipedal Stance Test performance	Change the time (s) in left and right unipedal stance.	4 months
Change the Static Full Tandem Test performance	Change the time (s) in full-tandem position.	4 months
Change the Walking Full Tandem Test performance	Achieve at least 10 steps in full-tandem.	4 months
Change the Time Up and Go Test performance	Change the time (s) in performing the Time Up and Go test.	4 months
Change the 6 minutes walk test performance	Change the distance (m) covered for 6 minutes of walking.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the Postural Stability (length displacement of Center of Pressure)	Significantly change the length displacement (mm) of center of pressure.	4 months
Change the Postural Stability (displacement of Center of Pressure)	Significantly change the amplitude mediolateral and anteroposterior displacement (mm) of Center of Pressure.	4 months
Change the Postural Stability (Ellipse surface)	Significantly change the ellipse surface (mm2).	4 months
Change the Postural Stability (Mean Speed of Center of Pressure)	Significantly change the mean speed of CoP (mm/s).	4 months
Change the Postural Stability (Standard deviation of Center of Pressure)	Significantly change the mediolateral and anteroposterior standard deviation (mm).	4 months
Change the Postural Stability (Root Mean Square)	Significantly change the root mean square index (mm).	4 months
Change the Postural Stability (Romberg Ration Index)	Significantly change the romberg ration index (mm).	4 months
Change the mean pressure in static position	Change the mean pressure (kPa) on each foot in static position.	4 months
Change the maximum pressure in static position	Change the maximum pressure (kPa) in each forefoot and hindfoot in static position.	4 months
Change the support surface in static position	Change the support surface (cm2) between the plantar surface and the platform sensors, during the support phase on each of the feet.	4 months
Change the load distribution in static position	Change the load distribution (%) between each foot.	4 months
Change the maximum pressure in gait	Change the maximum pressure (kPa) of each foot in gait.	4 months
Change the mean pressure in gait	Change the mean pressure (kPa) on each foot in gait.	4 months
Change the plantar impression length in gait	Change the plantar impression Length (mm) of each of the feet.	4 months
Change the support surface in gait	Change the support surface (cm2) of each foot.	4 months
Change the longitude of CoP in gait	Change the longitude of the center of pressure (mm) of each foot.	4 months
Change the load distribution in gait	Change the load distribution (%) between the forefoot and hindfoot and between the medial and lateral zone.	4 months
Change the foot progression angle of gait	Change the foot progression angle in gait.	4 months
Change the double support time of gait	Change the double support time (ms) in gait.	4 months
Change the support time of gait	Change the support time (ms) for each foot in gait.	4 months
Change the step length of gait	Change the step length (m) in gait.	4 months
Adherence to the intervention	Number of hours per day using the devices (telephone monitoring).	2 months
Self-Perception of improvements	Presence or not of improvements in feet/legs with the devices (telephone monitoring).	2 months
Satisfaction with devices	Level of Satisfaction (totally satisfied, quite satisfied, satisfied, little satisfied, dissatisfied) with the devices (telephone monitoring).	2 months

Collaborators and Investigators

• Sponsor: Universidade do Algarve
• Collaborators: University of Huelva; OKM Química Ortopédica S.L.; Lola - J. Andrade Ferreira Neves Lda; Instituto São João de Deus (ISJD); Ortobalance - Ortopedia Técnica e Desportiva; Sensor Médica; Pierre Fabre Portugal; Associação para o Estudo da Diabetes Mellitus e de Apoio ao Diabético do Algarve (AEDMADA); Unidade Funcional de Faro - Agrupamento de Centros de Saúde do Central
• Investigators: Principal Investigator: Marta Botelho, PhD, Researcher

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2017
• Primary Completion (ACTUAL): January 4, 2018
• Study Completion (ACTUAL): May 21, 2018

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (ACTUAL): October 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Functionality; Postural Balance; Footwear; Foot Orthoses
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Diabetes Mellitus; Neuromuscular Diseases; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases
• Other Study ID Numbers: 0348_CIE_6_E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No