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NCT05639478: FOCAIN
FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care
NA trial testing Foot-related exercises in Diabetes; Neuropathy, Polyneuropathy (Manifestation) in 356 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 356 |
| Start date | 1 March 2023 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Foot-related exercises
Conditions studied
- Diabetes; Neuropathy, Polyneuropathy (Manifestation) — all drugs for Diabetes; Neuropathy, Polyneuropathy (Manifestation) →
Sponsor
University of Sao Paulo General Hospital
Who can join
18 and older, any sex, with Diabetes; Neuropathy, Polyneuropathy (Manifestation). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Rodrigues CB, Soares PNC, Schmitt ACB, Sacco ICN. · · 2024 · cited 2× · PMID 38316587 · DOI 10.1136/bmjopen-2023-078958 -
From evidence to action: contextual determinants for the pre-implementation of a foot-ankle exercise program for diabetes in primary care.
Soares PNC, Sacco ICN, Rodrigues CB, Santos GS, et al · · 2026 · PMID 41527130 · DOI 10.1186/s12913-025-13971-4
Verify or expand the search:
- PubMed search for NCT05639478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05639478 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo General Hospital
- Last refreshed: 24 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05639478.
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