Diabetes; Neuropathy, Polyneuropathy (Manifestation)FOCAINNCT05639478
FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
A study testing Foot-related exercises in people with Diabetes; Neuropathy, Polyneuropathy (Manifestation), run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes; Neuropathy, Polyneuropathy (Manifestation)
- What is being tested?
- Foot-related exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2023to 31 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both sexes;
- Diabetes mellitus type 1 or 2;
- Residence within the catchment area of the Family Health Units.
- Availability to participate in the intervention at the established group time.
- Non-inclusion Criteria:
- Clinical diagnosis of dementia;
Show all 9Show fewer
- Inability to provide reliable and consistent information;
- Perform physiotherapy intervention throughout the intervention period;
- Active foot ulcer or major vascular complications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Read the detailed description
The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 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 face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.
- Being tested
- Foot-related exercises
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercises, musculoskeletal functions, primary health care
- Medical subject headings
- Diabetes Mellitus, Polyneuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot-related exercisesOther
Also called Intervention group
Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will perform face to face foot-related exercises for 12 weeks. Receives: Other: Foot-related 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-week Instrument
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 neuropathy)
Measured: 12 weeks
Change From Baseline of the Foot and Ankle range of motion at 12-week
Ankle and first metatarsophalangeal joint will be measured by manual goniometers.
Measured: 12 weeks
Secondary outcomes (11)
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week
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
Change from baseline of the toes and hallux strength at 12-week
Toes and hallux (summed) strength will be measured by a pressure plate with the subjects pressing down the plataform with toes standing.
Measured: 12 weeks
Change from baseline of the hallux strength at 12-week
Hallux strength will be measured by the paper grip test using a card where the examiner places it under the participant's hallux, asking the participant to hold it firmly with the hallux. The examiner pulls the card with increasing force while the participant resists
Measured: 12 weeks
Change From Baseline Time up and go at 12-week
Time spent for the subjects to rise from a standard arm chair, walk to a marker 3 m away, turn, walk back, and sit down again.
Measured: 12 weeks
Change from baseline of the Quality of life at 12-week
Score of the EQ-5D questionnaire answered by the participants, which is a generic instrument for measuring health-related quality of life that allows generating an index representing the value of an individual's health status.
Measured: 12 weeks
Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week
The presence of ulcers or pre-ulcerative lesions will be monitored through photos without identifying the participant. In cases of doubt, there will be a case discussion with a stoma therapist nurse, specialized in wounds on the feet of people with diabetes
Measured: 12 weeks
Change From Baseline in Disability at 12-Week Instrument
Score of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12-item version. This questionnaire assesses functioning and disability during the previous 30 days across different aspects of daily life, including cognition, mobility, self-care, getting along with others, life activities, and participation. Participants rate the level of difficulty experienced in 12 activities using a 5-point response scale ranging from no difficulty to extreme difficulty or inability to perform the activity. The responses are scored to obtain an overall functioning and disability score, with higher scores indicating greater disability. Additional questions assess the number of days during the previous 30 days in which difficulties were present, the participant was completely unable to perform usual activities or work, and usual activities or work were reduced because of the health condition.
Measured: 12 WEEKS
Healthcare Resource Utilization and Direct/Indirect Costs
Assessment of direct and indirect healthcare costs related to treatment. Information is collected via a standardized questionnaire assessing: 1) Public health resource use (SUS): prescribed medications, diagnostic tests, general practitioner and specialist visits, and physiotherapy sessions; 2) Out-of-pocket expenses: private consultations, tests, non-prescribed medications, complementary supplies (dressings/supplements), and healthcare-related transport (public and private); and 3) Indirect costs: paid and unpaid work absenteeism (hours lost due to health reasons) and monthly salary (in BRL) to estimate productivity loss.
Measured: 12 WEEKS
Reach of the implementation at 12-week
According to the RE-AIM tool, percentage of coverage and representativeness of people with diabetes participating in the intervention. It will be calculated at the individual level by dividing the population reached by the intervention by the total population of people with diabetes eligible for the intervention. Furthermore, the representativeness of this population will be observed based on sociodemographic data and compared to the non-participating group.
Measured: 12 weeks
Adoption of the implementation
According to the RE-AIM tool, percentage of coverage and representativeness of locations that we will implement (18 clusters) and key actors participating in phase 1 and in the professional training in phase 2. Representativeness of the participating units and professionals will also be considered in the analysis
Measured: End of phase 1, end of phase 2
Implementation at 12 weeks
According to the RE-AIM tool, fidelity to the initially proposed intervention will be evaluated qualitatively and quantitatively, as well as the adaptations - if carried out, through feedback during the course of implementation and in the final evaluation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Mar 2023
- Primary completion30 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes; Neuropathy, Polyneuropathy (Manifestation)Studies 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
- Parallel Assignment Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital
- Investigators
- Isabel CN Sacco, PhD, Study director, Associate Professor at Medicine of University of São PauloCarla BR da Silva, PT, Principal investigator, Researcher of School of Medicine of University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639478
- Sponsor's protocol ID
- FOCAIN
- Acronym
- FOCAIN
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodrigues CB, Soares PNC, Schmitt ACB, Sacco ICN. Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study. BMJ Open. 2024 Feb 5;14(2):e078958. doi: 10.1136/bmjopen-2023-078958.
PubMed 38316587
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life
- ClinicalTrials.gov ID
- NCT05639478
- Acronym / sponsor ID
- FOCAIN / FOCAIN
- Keywords
- exercise therapy, diabetic foot, preventive care, foot-related exercises, musculoskeletal functions, primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 6 Dec 2022 (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 type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Detailed description
The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 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 face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Foot-related exercisesPatients in the intervention group will perform face to face foot-related exercises for 12 weeks. |
| 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults of both sexes;
- Diabetes mellitus type 1 or 2;
- Residence within the catchment area of the Family Health Units.
- Availability to participate in the intervention at the established group time.
- Clinical diagnosis of dementia;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Foot-related exercisesAlso: Intervention groupFace to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression. | Other | Intervention group |
Primary outcome
Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument
Time frame: 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 neuropathy)
Change From Baseline of the Foot and Ankle range of motion at 12-week
Time frame: 12 weeks
Ankle and first metatarsophalangeal joint will be measured by manual goniometers.
11 secondary outcomes
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week
Time frame: 12 weeks
Change from baseline of the toes and hallux strength at 12-week
Time frame: 12 weeks
Change from baseline of the hallux strength at 12-week
Time frame: 12 weeks
Change From Baseline Time up and go at 12-week
Time frame: 12 weeks
Change from baseline of the Quality of life at 12-week
Time frame: 12 weeks
Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week
Time frame: 12 weeks
Change From Baseline in Disability at 12-Week Instrument
Time frame: 12 WEEKS
Healthcare Resource Utilization and Direct/Indirect Costs
Time frame: 12 WEEKS
Reach of the implementation at 12-week
Time frame: 12 weeks
Adoption of the implementation
Time frame: End of phase 1, end of phase 2
Implementation at 12 weeks
Time frame: 12 weeks
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 2 Nov 2026.
- Derived from this study: PubMed 38316587Rodrigues CB, Soares PNC, Schmitt ACB, Sacco ICN. Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study. BMJ Open. 2024 Feb 5;14(2):e078958. doi: 10.1136/bmjopen-2023-078958.
- University of Sao Paulo websiteLink provided by the sponsor.
- Description Laboratory of Biomechanics of Human Movement and Posture websiteLink 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 CN Sacco, PhD study director
Associate Professor at Medicine of University of São Paulo
Carla BR da Silva, PT principal investigator
Researcher of School of Medicine of University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot-related exercises in people with Diabetes; Neuropathy, Polyneuropathy (Manifestation), 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 9 inclusion and 0 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 2 Nov 2026. 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-week Instrument (time frame: 12 weeks). 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 NCT05639478, which also lists 1 linked publication.
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 2 Nov 2026.