Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605900
Recruitment Status : Completed
First Posted : October 28, 2020
Last Update Posted : October 30, 2020
Sponsor:
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
Information provided by (Responsible Party):
Marta Botelho, Universidade do Algarve

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).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy Device: Orthopedic Footwear Device: Standard Footwear Device: Plantar Orthoses Behavioral: Education on foot self-care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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
Official Title: Impact of Therapeutic Footwear and Plantar Orthoses for Patients With Diabetic Neuropathic Foot in Quality of Life and Functionality: A Interventional Study
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : January 4, 2018
Actual Study Completion Date : May 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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: 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: 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.




Primary Outcome Measures :
  1. Change the Quality of Life [ Time Frame: 4 months ]
    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.

  2. Change the Performance of Lower Extremity Functional Scale [ Time Frame: 4 months ]
    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.

  3. Change the Functional Reach Test performance [ Time Frame: 4 months ]
    Significantly change the maximum distance (cm) attained in Functional Reach Test.

  4. Change the Unipedal Stance Test performance [ Time Frame: 4 months ]
    Change the time (s) in left and right unipedal stance.

  5. Change the Static Full Tandem Test performance [ Time Frame: 4 months ]
    Change the time (s) in full-tandem position.

  6. Change the Walking Full Tandem Test performance [ Time Frame: 4 months ]
    Achieve at least 10 steps in full-tandem.

  7. Change the Time Up and Go Test performance [ Time Frame: 4 months ]
    Change the time (s) in performing the Time Up and Go test.

  8. Change the 6 minutes walk test performance [ Time Frame: 4 months ]
    Change the distance (m) covered for 6 minutes of walking.


Secondary Outcome Measures :
  1. Change the Postural Stability (length displacement of Center of Pressure) [ Time Frame: 4 months ]
    Significantly change the length displacement (mm) of center of pressure.

  2. Change the Postural Stability (displacement of Center of Pressure) [ Time Frame: 4 months ]
    Significantly change the amplitude mediolateral and anteroposterior displacement (mm) of Center of Pressure.

  3. Change the Postural Stability (Ellipse surface) [ Time Frame: 4 months ]
    Significantly change the ellipse surface (mm2).

  4. Change the Postural Stability (Mean Speed of Center of Pressure) [ Time Frame: 4 months ]
    Significantly change the mean speed of CoP (mm/s).

  5. Change the Postural Stability (Standard deviation of Center of Pressure) [ Time Frame: 4 months ]
    Significantly change the mediolateral and anteroposterior standard deviation (mm).

  6. Change the Postural Stability (Root Mean Square) [ Time Frame: 4 months ]
    Significantly change the root mean square index (mm).

  7. Change the Postural Stability (Romberg Ration Index) [ Time Frame: 4 months ]
    Significantly change the romberg ration index (mm).

  8. Change the mean pressure in static position [ Time Frame: 4 months ]
    Change the mean pressure (kPa) on each foot in static position.

  9. Change the maximum pressure in static position [ Time Frame: 4 months ]
    Change the maximum pressure (kPa) in each forefoot and hindfoot in static position.

  10. Change the support surface in static position [ Time Frame: 4 months ]
    Change the support surface (cm2) between the plantar surface and the platform sensors, during the support phase on each of the feet.

  11. Change the load distribution in static position [ Time Frame: 4 months ]
    Change the load distribution (%) between each foot.

  12. Change the maximum pressure in gait [ Time Frame: 4 months ]
    Change the maximum pressure (kPa) of each foot in gait.

  13. Change the mean pressure in gait [ Time Frame: 4 months ]
    Change the mean pressure (kPa) on each foot in gait.

  14. Change the plantar impression length in gait [ Time Frame: 4 months ]
    Change the plantar impression Length (mm) of each of the feet.

  15. Change the support surface in gait [ Time Frame: 4 months ]
    Change the support surface (cm2) of each foot.

  16. Change the longitude of CoP in gait [ Time Frame: 4 months ]
    Change the longitude of the center of pressure (mm) of each foot.

  17. Change the load distribution in gait [ Time Frame: 4 months ]
    Change the load distribution (%) between the forefoot and hindfoot and between the medial and lateral zone.

  18. Change the foot progression angle of gait [ Time Frame: 4 months ]
    Change the foot progression angle in gait.

  19. Change the double support time of gait [ Time Frame: 4 months ]
    Change the double support time (ms) in gait.

  20. Change the support time of gait [ Time Frame: 4 months ]
    Change the support time (ms) for each foot in gait.

  21. Change the step length of gait [ Time Frame: 4 months ]
    Change the step length (m) in gait.

  22. Adherence to the intervention [ Time Frame: 2 months ]
    Number of hours per day using the devices (telephone monitoring).

  23. Self-Perception of improvements [ Time Frame: 2 months ]
    Presence or not of improvements in feet/legs with the devices (telephone monitoring).

  24. Satisfaction with devices [ Time Frame: 2 months ]
    Level of Satisfaction (totally satisfied, quite satisfied, satisfied, little satisfied, dissatisfied) with the devices (telephone monitoring).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605900


Locations
Layout table for location information
Portugal
Marta Botelho
Faro, Algarve, Portugal, 8005-139
Sponsors and Collaborators
Universidade do Algarve
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
Layout table for investigator information
Principal Investigator: Marta Botelho, PhD Researcher
Layout table for additonal information
Responsible Party: Marta Botelho, Research Fellowship, Universidade do Algarve
ClinicalTrials.gov Identifier: NCT04605900    
Other Study ID Numbers: 0348_CIE_6_E
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Botelho, Universidade do Algarve:
Quality of life
Postural Balance
Functionality
Foot Orthoses
Footwear
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases