Foot care and exercise program for people with diabetes
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
This study is testing a 12-week group exercise program for people with diabetes to see if it helps improve foot health and overall quality of life compared to regular foot care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 356 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (Limeira, São Paulo) |
| Trial ID | NCT05639478 on ClinicalTrials.gov |
What this trial studies
This trial aims to implement a 12-week program of group foot and ankle exercises for individuals with diabetic foot in primary care settings. It involves training primary care workers to deliver the intervention effectively while monitoring clinical outcomes such as functional status and quality of life. The study will follow a hybrid implementation effectiveness design, assessing both the intervention's clinical impact and the strategies used for its implementation. Participants will be randomly assigned to either a control group receiving standard foot care or an intervention group participating in the exercise program.
Who should consider this trial
Good fit: Ideal candidates include individuals with type 1 or type 2 diabetes who can walk independently and are willing to participate in group exercises.
Not a fit: Patients with active foot ulcers, major vascular complications, or those undergoing other physiotherapy interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the foot health and overall quality of life for patients with diabetes.
How similar studies have performed: Other studies have shown positive outcomes with similar exercise interventions for diabetic foot care, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Limeira, São Paulo
- Equipe Multidisciplinar E-Multi — Limeira, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Carla BR da Silva, PT — Researcher of School of Medicine of University of São Paulo
- Study coordinator: Isabel CN Sacco, PhD
- Email: icnsacco@usp.br
- Phone: +551130918426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.