Diabetes Mellitus, Type 2NCT04605900
Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
A study testing Orthopedic Footwear, Standard Footwear and Plantar Orthoses in people with Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by Universidade do Algarve at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy
- What is being tested?
- Orthopedic Footwear, Standard Footwear and Plantar Orthoses
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePortugal
- Study dates
- 13 Mar 2017to 21 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Orthopedic Footwear, Standard Footwear, Plantar Orthoses, Education on foot self-care
- Keywords
- Quality of life, Postural Balance, Functionality, Foot Orthoses, Footwear
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic FootwearDevice
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 FootwearDevice
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 OrthosesDevice
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.
Education on foot self-careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Footwear (SF) | Experimental | Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear. Receives: Device: Standard Footwear; Device: Plantar Orthoses; Behavioral: Education on foot self-care |
| Orthopedic Footwear (OF) | Experimental | Intervention: plantar orthoses, education on foot self-care and orthopedic footwear. Receives: Device: Orthopedic Footwear; Device: Plantar Orthoses; Behavioral: Education on foot self-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Change the Functional Reach Test performance
Significantly change the maximum distance (cm) attained in Functional Reach Test.
Measured: 4 months
Change the Unipedal Stance Test performance
Change the time (s) in left and right unipedal stance.
Measured: 4 months
Change the Static Full Tandem Test performance
Change the time (s) in full-tandem position.
Measured: 4 months
Change the Walking Full Tandem Test performance
Achieve at least 10 steps in full-tandem.
Measured: 4 months
Change the Time Up and Go Test performance
Change the time (s) in performing the Time Up and Go test.
Measured: 4 months
Change the 6 minutes walk test performance
Change the distance (m) covered for 6 minutes of walking.
Measured: 4 months
Secondary outcomes (24)
Change the Postural Stability (length displacement of Center of Pressure)
Significantly change the length displacement (mm) of center of pressure.
Measured: 4 months
Change the Postural Stability (displacement of Center of Pressure)
Significantly change the amplitude mediolateral and anteroposterior displacement (mm) of Center of Pressure.
Measured: 4 months
Change the Postural Stability (Ellipse surface)
Significantly change the ellipse surface (mm2).
Measured: 4 months
Change the Postural Stability (Mean Speed of Center of Pressure)
Significantly change the mean speed of CoP (mm/s).
Measured: 4 months
Change the Postural Stability (Standard deviation of Center of Pressure)
Significantly change the mediolateral and anteroposterior standard deviation (mm).
Measured: 4 months
Change the Postural Stability (Root Mean Square)
Significantly change the root mean square index (mm).
Measured: 4 months
Change the Postural Stability (Romberg Ration Index)
Significantly change the romberg ration index (mm).
Measured: 4 months
Change the mean pressure in static position
Change the mean pressure (kPa) on each foot in static position.
Measured: 4 months
Change the maximum pressure in static position
Change the maximum pressure (kPa) in each forefoot and hindfoot in static position.
Measured: 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.
Measured: 4 months
Change the load distribution in static position
Change the load distribution (%) between each foot.
Measured: 4 months
Change the maximum pressure in gait
Change the maximum pressure (kPa) of each foot in gait.
Measured: 4 months
Change the mean pressure in gait
Change the mean pressure (kPa) on each foot in gait.
Measured: 4 months
Change the plantar impression length in gait
Change the plantar impression Length (mm) of each of the feet.
Measured: 4 months
Change the support surface in gait
Change the support surface (cm2) of each foot.
Measured: 4 months
Change the longitude of CoP in gait
Change the longitude of the center of pressure (mm) of each foot.
Measured: 4 months
Change the load distribution in gait
Change the load distribution (%) between the forefoot and hindfoot and between the medial and lateral zone.
Measured: 4 months
Change the foot progression angle of gait
Change the foot progression angle in gait.
Measured: 4 months
Change the double support time of gait
Change the double support time (ms) in gait.
Measured: 4 months
Change the support time of gait
Change the support time (ms) for each foot in gait.
Measured: 4 months
Change the step length of gait
Change the step length (m) in gait.
Measured: 4 months
Adherence to the intervention
Number of hours per day using the devices (telephone monitoring).
Measured: 2 months
Self-Perception of improvements
Presence or not of improvements in feet/legs with the devices (telephone monitoring).
Measured: 2 months
Satisfaction with devices
Level of Satisfaction (totally satisfied, quite satisfied, satisfied, little satisfied, dissatisfied) with the devices (telephone monitoring).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start13 Mar 2017
- Primary completion4 Jan 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pre and post-test analysis was performed.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Algarve
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Marta Botelho, Universidade do Algarve
- Investigators
- Marta Botelho, PhD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605900
- Sponsor's protocol ID
- 0348_CIE_6_E
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Footwear and Plantar Orthoses for Patients With Diabetic Neuropathic Foot in Quality of Life and Functionality: A Interventional Study
- ClinicalTrials.gov ID
- NCT04605900
- Acronym / sponsor ID
- 0348_CIE_6_E
- Keywords
- Quality of life, Postural Balance, Functionality, Foot Orthoses, Footwear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidade do AlgarveUniversity, hospital or other
- 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
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre and post-test analysis was performed.
| Arm | Type | Receives |
|---|---|---|
| Standard Footwear (SF) | Experimental | Device: Standard Footwear, Device: Plantar Orthoses, Behavioral: Education on foot self-careIntervention: plantar orthoses, education on foot self-care and appropriate standard footwear. |
| Orthopedic Footwear (OF) | Experimental | Device: Orthopedic Footwear, Device: Plantar Orthoses, Behavioral: Education on foot self-careIntervention: plantar orthoses, education on foot self-care and orthopedic footwear. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Active ulceration;
- Severe osteoarticular deformities;
- Presence of cognitive impairment;
- Gait with technical devices;
- Diagnosis of neurological pathology that can affect the gait pattern;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopedic FootwearThe 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 | Orthopedic Footwear (OF) |
| Standard FootwearIn 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 | Standard Footwear (SF) |
| Plantar OrthosesThe 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. | Device | Orthopedic Footwear (OF), Standard Footwear (SF) |
| Education on foot self-careAn 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. | Behavioural | Orthopedic Footwear (OF), Standard Footwear (SF) |
Primary outcome
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.
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.
Change the Functional Reach Test performance
Time frame: 4 months
Significantly change the maximum distance (cm) attained in Functional Reach Test.
Change the Unipedal Stance Test performance
Time frame: 4 months
Change the time (s) in left and right unipedal stance.
Change the Static Full Tandem Test performance
Time frame: 4 months
Change the time (s) in full-tandem position.
Change the Walking Full Tandem Test performance
Time frame: 4 months
Achieve at least 10 steps in full-tandem.
Change the Time Up and Go Test performance
Time frame: 4 months
Change the time (s) in performing the Time Up and Go test.
Change the 6 minutes walk test performance
Time frame: 4 months
Change the distance (m) covered for 6 minutes of walking.
24 secondary outcomes
Change the Postural Stability (length displacement of Center of Pressure)
Time frame: 4 months
Change the Postural Stability (displacement of Center of Pressure)
Time frame: 4 months
Change the Postural Stability (Ellipse surface)
Time frame: 4 months
Change the Postural Stability (Mean Speed of Center of Pressure)
Time frame: 4 months
Change the Postural Stability (Standard deviation of Center of Pressure)
Time frame: 4 months
Change the Postural Stability (Root Mean Square)
Time frame: 4 months
Change the Postural Stability (Romberg Ration Index)
Time frame: 4 months
Change the mean pressure in static position
Time frame: 4 months
Change the maximum pressure in static position
Time frame: 4 months
Change the support surface in static position
Time frame: 4 months
Change the load distribution in static position
Time frame: 4 months
Change the maximum pressure in gait
Time frame: 4 months
Change the mean pressure in gait
Time frame: 4 months
Change the plantar impression length in gait
Time frame: 4 months
Change the support surface in gait
Time frame: 4 months
Change the longitude of CoP in gait
Time frame: 4 months
Change the load distribution in gait
Time frame: 4 months
Change the foot progression angle of gait
Time frame: 4 months
Change the double support time of gait
Time frame: 4 months
Change the support time of gait
Time frame: 4 months
Change the step length of gait
Time frame: 4 months
Adherence to the intervention
Time frame: 2 months
Self-Perception of improvements
Time frame: 2 months
Satisfaction with devices
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Botelho, PhD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopedic Footwear, Standard Footwear and Plantar Orthoses in people with Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by Universidade do Algarve at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the Quality of Life (time frame: 4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.