Diabetic NeuropathiesFOCA-INCT04011267
Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy
A study testing Physical therapy by foot-ankle segmental and functional exercises in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Physical therapy by foot-ankle segmental and functional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 1 Sep 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 1 or 2;
- Moderate or severe neuropathy confirmed with the fuzzy software;
- Ability to walk independently in the laboratory ;
- Accessibility to electronic devices (computers, mobile devices, tablets, etc.) access to exercise software.
Who cannot join
- Hallux amputation or total amputation of the foot;
- History of surgical procedure in the knee, ankle or hip;
- History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
- Neurological and / or rheumatologic diseases diagnosed;
- Inability to provide consistent information;
- Perform physiotherapy intervention throughout the intervention period;
Show all 11Show fewer
- Receiving any physiotherapy intervention or offloading devices;
- Major vascular complications;
- Severe retinopathy;
- Ulceration not healed for at least 6 months and / or active ulcer;
- Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial
The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
Read the detailed description
A randomized controlled trial will be performed with 62 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System) software for 12-weeks. The exercise program is customized during the performance by a perceived effort scale reported by the participant.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle joint moment during gait (infrared cameras and force plate), (5) plantar pressure distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot isometric strength (pressure plate measurement), (10) functional balance reach test.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
- Conditions
- Diabetic Neuropathies
- Being tested
- Physical therapy by foot-ankle segmental and functional exercises
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercises, self-management, software, musculoskeletal function
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy by foot-ankle segmental and functional exercisesOther
The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study. Receives: Other: Physical therapy by foot-ankle segmental and functional exercises |
| Control Group | No intervention | Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Diabetic neuropathy symptoms at 12-weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the diabetic neuropathy).
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-weeks
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture, available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Measured: 12-weeks, 24-weeks (follow-up)
Secondary outcomes (10)
Change from Baseline of the foot and ankle kinematics during gait at 12-weeks
Ankle \& Foot joints and plantar arch motion: maximum, minimum and range of motion (degrees) during gait
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline of the foot-ankle joint moment during gait at 12-weeks
maximum foot-ankle joint moment (joint loads N.m), calculated by inverse dynamics during gait.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12-weeks
A pressure platform (emed®-q100, novel, Germany) will be used to evaluate the pressure pattern during walking. The analysis of plantar pressure will be through the parameters: peak pressure (kPa), pressure - time integral (kPa/s) in each plantar area.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Tactile sensitivity at 12-weeks
Tactile sensorial deficits will be evaluated by monofilament with a tactile stimulus of a 10-g monofilament in 4 plantar areas (plantar face of the hallux, heads of 1st, 3rd and 5th metatarsals). The areas will be evaluated in random order and not allowing the participant to view the monofilament. The number of areas where the participant does not feel the pressure will be indicated. The greater the number of areas marked without sensing, the greater the impairment of tactile sensitivity.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Vibration sensitivity at 12-weeks
The vibration sensitivity will be assessed by vibrating a tuning fork (128Hz) in the dorsal region of the distal hallux phalanx. The participant should report the moment he/she does no longer feel the vibration of the tuning fork, and the evaluator must time the interval between which the participant reports that he/she ceases to feel the vibration and the moment the evaluator ceases to feel the vibration in the his/her hand. Values smaller than 10 seconds will be classified with present vibratory sensitivity; values greater than 10 seconds will be classified as decreased vibratory sensitivity. If the participant does not perceive the vibration imposed by the tuning fork, it will be classified as absent vibratory sensitivity.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Foot health and functionality at 12-weeks
The Brazilian version of the Foot-Health Status Questionnaire (FHSQ-BR) will be used. This instrument is divided into three domains and we are using domains I and II. The first domain evaluates the foot in four spheres: pain, function, footwear and general health. The second domain evaluates the general state of health, also in four spheres: general health, physical activity, social capacity and vitality. Domains I and II are composed of questions with answer choices that are presented in the affirmative sentences and corresponding numbers. Domain III, which is not being used, comprises the collection of general demographic data of individuals. Each domain receives a score from 0 to 100, where 100 expresses the best condition and 0 to worst.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Foot isometric strength at 12-weeks
The muscle strength of the flexor muscles of the hallux and flexors of the toes will be evaluated using the emed®-q100 pressure platform (novel, Germany) according to a test protocol already described elsewhere. The individual should stand, with the evaluated foot centered on the pressure platform, instructed to make as much force as possible with the hallux and toes in order to press them against the platform ("squeeze the platform with the toes"). Peak values of maximum force (N) will be extracted. The values will be normalized by bodyweight.
Measured: 12-weeks, 24-weeks (follow-up)
Change from Baseline Functional balance at 12-weeks
It is a clinical test where the patient will be standing barefoot, perpendicular to the wall, with the shoulder flexed 90° and the elbow extended. A tape measure will be attached to the wall, parallel to the floor, positioned at the height of the patient's acromion. The volunteer will be instructed to lean forward as much as possible without losing balance or taking a step. The displacement of the wrist will be measured by the tape. The greater the distance in centimeter, the better the functional balance.
Measured: 12-weeks, 24-weeks (follow-up)
Cost Effectiveness and cost utility
Assessments of costs by an specific questionnaire and the database of the public health system
Measured: 12-weeks, 24-weeks (follow-up)
Quality Adjusted Life Years
Quality adjusted life years will be measured by the EQ-5D-3L questionnaire
Measured: 12-weeks, 24-weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital
- Investigators
- Isabel de Camargo Neves Sacco, PhD, Principal investigator, Associate Professor at São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011267
- Sponsor's protocol ID
- FOCA-I
- Acronym
- FOCA-I
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2019
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira JSSP, Cruvinel-Junior RH, da Silva EQ, Verissimo JL, Monteiro RL, Duarte M, Giacomozzi C, Sacco ICN. Effectiveness of a web-based foot-ankle exercise program for treating ulcer risk factors in diabetic neuropathy in a randomized controlled trial. Sci Rep. 2024 Nov 8;14(1):27291. doi: 10.1038/s41598-024-78188-7.
PubMed 39516524Cruvinel-Junior RH, Ferreira JSSP, Verissimo JL, Monteiro RL, Silva EQ, Suda EY, Sacco ICN. Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation. Sci Rep. 2024 Jul 12;14(1):16094. doi: 10.1038/s41598-024-67176-6.
PubMed 38997439Cruvinel Junior RH, Ferreira JSSP, Beteli RI, Silva EQ, Verissimo JL, Monteiro RL, Suda EY, Sacco ICN. Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I. Pilot Feasibility Stud. 2021 Mar 26;7(1):87. doi: 10.1186/s40814-021-00826-y.
PubMed 33766146Ferreira JSSP, Cruvinel Junior RH, Silva EQ, Verissimo JL, Monteiro RL, Pereira DS, Suda EY, Sartor CD, Sacco ICN. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials. 2020 Jan 13;21(1):73. doi: 10.1186/s13063-019-4017-9.
PubMed 31931855
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04011267
- Acronym / sponsor ID
- FOCA-I / FOCA-I
- Conditions
- Diabetic Neuropathies
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercises, self-management, software, musculoskeletal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Jul 2019 (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.
The main objective of this trial is to investigate the effect of a customized foot-related exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
Detailed description
A randomized controlled trial will be performed with 62 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System) software for 12-weeks. The exercise program is customized during the performance by a perceived effort scale reported by the participant.
The subjects will be evaluated in 3 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle joint moment during gait (infrared cameras and force plate), (5) plantar pressure distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot isometric strength (pressure plate measurement), (10) functional balance reach test.
The hypothesis of this study is that the intervention will increase the perception of the tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, increase the functional balance score, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, promote a more physiological foot rollover with a redistribution of plantar pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention. There will be also beneficial biomechanical changes during gait, such as: (1) increase in the ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in the ankle flexor moment and ankle eccentric power in the load phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Physical therapy by foot-ankle segmental and functional exercisesPatients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study. |
| Control Group | No intervention | –Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes mellitus type 1 or 2;
- Moderate or severe neuropathy confirmed with the fuzzy software;
- Ability to walk independently in the laboratory ;
- Accessibility to electronic devices (computers, mobile devices, tablets, etc.) access to exercise software.
Key exclusion criteria (11 listed)
- Hallux amputation or total amputation of the foot;
- History of surgical procedure in the knee, ankle or hip;
- History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
- Neurological and / or rheumatologic diseases diagnosed;
- Inability to provide consistent information;
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 |
|---|---|---|
| Physical therapy by foot-ankle segmental and functional exercisesThe physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed. | Other | Intervention Group |
Primary outcome
Change from Baseline Diabetic neuropathy symptoms at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the diabetic neuropathy).
Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture, available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
10 secondary outcomes
Change from Baseline of the foot and ankle kinematics during gait at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline of the foot-ankle joint moment during gait at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Tactile sensitivity at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Vibration sensitivity at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Foot health and functionality at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Foot isometric strength at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Change from Baseline Functional balance at 12-weeks
Time frame: 12-weeks, 24-weeks (follow-up)
Cost Effectiveness and cost utility
Time frame: 12-weeks, 24-weeks (follow-up)
Quality Adjusted Life Years
Time frame: 12-weeks, 24-weeks (follow-up)
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 3 Mar 2023.
- Derived from this study: PubMed 39516524Ferreira JSSP, Cruvinel-Junior RH, da Silva EQ, Verissimo JL, Monteiro RL, Duarte M, Giacomozzi C, Sacco ICN. Effectiveness of a web-based foot-ankle exercise program for treating ulcer risk factors in diabetic neuropathy in a randomized controlled trial. Sci Rep. 2024 Nov 8;14(1):27291. doi: 10.1038/s41598-024-78188-7.
- Derived from this study: PubMed 38997439Cruvinel-Junior RH, Ferreira JSSP, Verissimo JL, Monteiro RL, Silva EQ, Suda EY, Sacco ICN. Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation. Sci Rep. 2024 Jul 12;14(1):16094. doi: 10.1038/s41598-024-67176-6.
- Derived from this study: PubMed 33766146Cruvinel Junior RH, Ferreira JSSP, Beteli RI, Silva EQ, Verissimo JL, Monteiro RL, Suda EY, Sacco ICN. Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I. Pilot Feasibility Stud. 2021 Mar 26;7(1):87. doi: 10.1186/s40814-021-00826-y.
- Derived from this study: PubMed 31931855Ferreira JSSP, Cruvinel Junior RH, Silva EQ, Verissimo JL, Monteiro RL, Pereira DS, Suda EY, Sartor CD, Sacco ICN. Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I. Trials. 2020 Jan 13;21(1):73. doi: 10.1186/s13063-019-4017-9.
- University of Sao Paulo websiteLink provided by the sponsor.
- Laboratory of Biomechanics of Human Movement and Posture websiteLink provided by the sponsor.
- Educational Diabetic Foot SoftwareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Isabel de Camargo Neves Sacco, PhD principal investigator
Associate Professor at São Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy by foot-ankle segmental and functional exercises in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 11 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 3 Mar 2023. 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 Brazil. 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 from Baseline Diabetic neuropathy symptoms at 12-weeks (time frame: 12-weeks, 24-weeks (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011267, which also lists 4 linked publications.
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 3 Mar 2023.