NCT05639478 FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
| NCT ID | NCT05639478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Diabetes; Neuropathy, Polyneuropathy (Manifestation) |
| Study Type | INTERVENTIONAL |
| Enrollment | 356 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 356 participants in total. It began in 2023-03-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
Eligibility Criteria
Inclusion Criteria: * 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; * Inability to provide reliable and consistent information; * Perform physiotherapy intervention throughout the intervention period; * Active foot ulcer or major vascular complications.
Contact & Investigator
Isabel CN Sacco, PhD
STUDY DIRECTOR
Associate Professor at Medicine of University of São Paulo
Frequently Asked Questions
Who can join the NCT05639478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes; Neuropathy, Polyneuropathy (Manifestation). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05639478 currently recruiting?
Yes, NCT05639478 is actively recruiting participants. Contact the research team at icnsacco@usp.br for enrollment information.
Where is the NCT05639478 trial being conducted?
This trial is being conducted at Limeira, Brazil.
Who is sponsoring the NCT05639478 clinical trial?
NCT05639478 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Isabel CN Sacco, PhD at Associate Professor at Medicine of University of São Paulo. The trial plans to enroll 356 participants.
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