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FOot CAre and Exercises ImplementatioN for People With Diabetes in Primary Care

Study acronym: FOCAIN
StatusRecruiting
PhaseNot applicable
Started2023-03-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 12, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 30, 2026 → Aug 30, 2026
See other at-risk trials from University of Sao Paulo General Hospital

Amendment history

2026-08-10
Study Status, Outcome Measures v6
Primary completion pushed: 2026-06-30 → 2026-08-30
Completion pushed: 2026-08-31 → 2026-12-31
Secondary endpoints9 to 11 entries
Change From Baseline in Disability at 12-Week Instrument Healthcare Resource Utilization and Direct/Indirect Costs
2026-02-20
Study Status, Eligibility v5
Primary completion date2025-12-31→2026-06-30
Eligibility criteria-35 characters
Inclusion Criteria: Adults of both sexes; Diabetes mellitus type 1 or 2; BeResidence ablewithin tothe providecatchment consistentarea information;of the Family Health Units. Ability to walk independently for at least 10 meters; Availability to participate in the intervention at the established group time. ExclusionNon-inclusion Criteria: NeurologicalClinical diagnosis of dementia; Inability to provide reliable and /consistent or rheumatologic diseases diagnosedinformation; Perform physiotherapy intervention throughout the intervention period; Receiving any physiotherapy intervention or offload [...] [...]
2025-03-24
Enrolling by Invitation→Recruiting Study Status, Contacts/Locations v4
Trial statusEnrolling by Invitation→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-12-19
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Eligibility criteria-7 characters
Inclusion Criteria: Diabetes mellitus type 1 or 2; Be able to read e provide consistent information; Ability to walk independent [...]
Secondary endpoints8 to 9 entries
Change From Baseline of the FootFuzzy and Ankle rangeClassification of motionthe Diabetic Neuropathy Severity at 812-week Change from baseline of the toes and hallux strength at 812-week Change from baseline of the hallux strength at 812-week Change forFrom Baseline Time up and go at 12-week Change from baseline of the Quality of life at 812-week Reach of the implementation at 8-week Implementation at 8 weeks Change From Baseline of the foot ulcers and pre ulcerative lesions at 812-week Reach of the implementation at 12-week Implementation at 12 weeks
Primary endpoints2 entries, revised
Change From Baseline Diabetic Neuropathy Symptoms at 812-week Instrument Change From Baseline of the FuzzyFoot Classificationand Ankle range of the Diabetic Neuropathy Severitymotion at 812-week
Study description-148 characters
[...] fined in phase 1, developing strategies for the training of NASFprimary physiotherapists,care in addition to the capacitation of the physiotherapists on the proposed clinical interventionworkers. In phase 3, we will implement the intervention either usin [...] -related, functional and quality of life outcomes after the 812 weeks of intervention. Reach, adoption and implementation w [...] face to face exercises, supervised by physiotherapists for 812-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 812 weeks, for all outcomes. The following ou [...] [...]
Study sites1 entry, revised
NucleoEquipe deMultidisciplinar Apoio A Saude Da Família NasfE-Multi
2023-03-24
Not Yet Recruiting→Enrolling by Invitation Study Status, Study Description, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Enrolling by Invitation
Primary completion date2024-01-31→2025-12-31
Completion date2025-03-30→2026-08-31
Study sites0→1
Secondary endpoints3 to 8 entries
Change from baseline of the hallux strength at 8-week Reach of the implementation at 8-week Adoption of the implementation Implementation at 8 weeks Change From Baseline of the foot ulcers and pre ulcerative lesions at 8-week
Study description+1,328 characters
AThe 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 charac [...] randomized controlled trial will be performed with 356 pati [...]
2022-12-06
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 3 entries
Study description-2 characters
[...] score of the neuropathy severity, (3) tactile and vibration sensititivitysensitivity (10-g monofilament and tuning fork), (4) range of motion of [...]
2022-12-05
Original filing
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.
Trial Details
NCT Number NCT05639478
Lead Sponsor University of Sao Paulo General Hospital
Conditions Diabetes; Neuropathy, Polyneuropathy (Manifestation)
Enrollment 356 participants
Start Date 2023-03-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12