Multifactorial approaches to prevent foot ulcers in people with diabetic foot
Official title: Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
Run by Istituto Ortopedico Rizzoli · NCT07021222 · Data updated 2026-11-12
This project will test whether combining biomechanical imaging, clinical exams, metabolic checks, and lab tests can help predict and prevent foot ulcers in adults with type 2 diabetes who either have moderate ulcer risk or healed past ulcers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | March 15, 2027 |
| Study ends | May 15, 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07021222 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with type 2 diabetes who either have moderate ulceration risk (grade 2) with no prior foot ulcers or have a history of foot ulcers that have been healed for at least six months (grade 3).
✕Probably not a fit
People with active foot ulcers or ongoing infections, current cancer, on immunosuppressive or systemic corticosteroid therapy, pregnant or breastfeeding, unable to consent, or outside the eligible age/type 2 diabetes criteria are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a national, no-profit, multicentre effort that enrolls two groups of adults with type 2 diabetes: those with moderate risk for foot ulcers and those with prior ulcers healed at least six months. Each participant undergoes a battery of multi-instrumental measurements at baseline and again at 12 months, including weight-bearing CT-based biomechanical and functional analyses, clinical and metabolic assessments, and advanced biological and biochemical testing. Different centres contribute complementary testing, and data from the three sites are compared to identify combinations of risk and predisposition factors. The study uses a multidisciplinary approach to integrate these measurements into risk profiles that might inform prevention strategies.
Why it matters
Potential benefit: If successful, the approach could enable earlier identification of people at high risk for foot ulcers and support targeted prevention to reduce new ulcers and complications.
How similar studies have gone: Individual components such as biomechanical assessment and metabolic profiling have shown promise for predicting ulcer risk, but combining weight-bearing CT, advanced biochemistry, and multidisciplinary measures into a single predictive approach is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria for population 1: * Male and female patients aged between 18 and 75 years. * Diabetes mellitus type-2 patients with mild to moderate risk of ulceration at the foot (grade 2). Inclusion Criteria for population 2: * Male and female patients aged between 18 and 75 years. * Patients with diabetes mellitus type-2 and diabetic foot with an history of ulcerative lesions (grade 3), healed for at least 6 months. Exclusion Criteria for population 1: * History or evidence of ulcers at the foot * Infections in progress, ongoing neoplasms * Immunosuppressive therapies, and cortisone-based therapy * Pregnancy and lactation * Inability to provide informed consent Exclusion Criteria for population 2: * Infections in progress, ongoing neoplasms * Immunosuppressive therapies, and cortisone-based therapy * Pregnancy and lactation * Inability to provide informed consent
Where it's running
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Istituto Ortopedico Rizzoli
Bologna, Bo, Italy Recruiting
Study contacts
- Study coordinator: Lisa Berti, MD
- Email: lisa.berti@ior.it
- Phone: 051.63.66
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.