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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605900
• Other study ID #: 0348_CIE_6_E
• Status: Completed
• Phase: N/A
• Start date: March 13, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: October 2020
• Source: Universidade do Algarve
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 21, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Portugal	Marta Botelho	Faro	Algarve

Sponsors (10)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change the Functional Reach Test performance	Significantly change the maximum distance (cm) attained in Functional Reach Test.	4 months
Primary	Change the Unipedal Stance Test performance	Change the time (s) in left and right unipedal stance.	4 months
Primary	Change the Static Full Tandem Test performance	Change the time (s) in full-tandem position.	4 months
Primary	Change the Walking Full Tandem Test performance	Achieve at least 10 steps in full-tandem.	4 months
Primary	Change the Time Up and Go Test performance	Change the time (s) in performing the Time Up and Go test.	4 months
Primary	Change the 6 minutes walk test performance	Change the distance (m) covered for 6 minutes of walking.	4 months
Secondary	Change the Postural Stability (length displacement of Center of Pressure)	Significantly change the length displacement (mm) of center of pressure.	4 months
Secondary	Change the Postural Stability (displacement of Center of Pressure)	Significantly change the amplitude mediolateral and anteroposterior displacement (mm) of Center of Pressure.	4 months
Secondary	Change the Postural Stability (Ellipse surface)	Significantly change the ellipse surface (mm2).	4 months
Secondary	Change the Postural Stability (Mean Speed of Center of Pressure)	Significantly change the mean speed of CoP (mm/s).	4 months
Secondary	Change the Postural Stability (Standard deviation of Center of Pressure)	Significantly change the mediolateral and anteroposterior standard deviation (mm).	4 months
Secondary	Change the Postural Stability (Root Mean Square)	Significantly change the root mean square index (mm).	4 months
Secondary	Change the Postural Stability (Romberg Ration Index)	Significantly change the romberg ration index (mm).	4 months
Secondary	Change the mean pressure in static position	Change the mean pressure (kPa) on each foot in static position.	4 months
Secondary	Change the maximum pressure in static position	Change the maximum pressure (kPa) in each forefoot and hindfoot in static position.	4 months
Secondary	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
Secondary	Change the load distribution in static position	Change the load distribution (%) between each foot.	4 months
Secondary	Change the maximum pressure in gait	Change the maximum pressure (kPa) of each foot in gait.	4 months
Secondary	Change the mean pressure in gait	Change the mean pressure (kPa) on each foot in gait.	4 months
Secondary	Change the plantar impression length in gait	Change the plantar impression Length (mm) of each of the feet.	4 months
Secondary	Change the support surface in gait	Change the support surface (cm2) of each foot.	4 months
Secondary	Change the longitude of CoP in gait	Change the longitude of the center of pressure (mm) of each foot.	4 months
Secondary	Change the load distribution in gait	Change the load distribution (%) between the forefoot and hindfoot and between the medial and lateral zone.	4 months
Secondary	Change the foot progression angle of gait	Change the foot progression angle in gait.	4 months
Secondary	Change the double support time of gait	Change the double support time (ms) in gait.	4 months
Secondary	Change the support time of gait	Change the support time (ms) for each foot in gait.	4 months
Secondary	Change the step length of gait	Change the step length (m) in gait.	4 months
Secondary	Adherence to the intervention	Number of hours per day using the devices (telephone monitoring).	2 months
Secondary	Self-Perception of improvements	Presence or not of improvements in feet/legs with the devices (telephone monitoring).	2 months
Secondary	Satisfaction with devices	Level of Satisfaction (totally satisfied, quite satisfied, satisfied, little satisfied, dissatisfied) with the devices (telephone monitoring).	2 months