Diabetes Mellitus Foot UlcerDARE-DiaFootNCT07021222
Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)
A study testing Full Analysis and Partial Analysis in people with Diabetes Mellitus Foot Ulcer, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Foot Ulcer
- What is being tested?
- Full Analysis and Partial Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2025to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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
- Infections in progress, ongoing neoplasms
Show all 9Show fewer
- Immunosuppressive therapies, and cortisone-based therapy
- Pregnancy and lactation
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, BO, 40136
About this study
Official title: Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
Read the detailed description
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
A first population has no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); a second population is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
One centre provides thorough biomechanical and functional analyses also based on modern Computed Tomography in weight-bearing; another centre performs state-of-the-art clinical assessments and metabolic analyses; the third centre performs the latter, together with advanced biological and biochemical analyses.
Comparisons of all these multi-instrumental measurements between the two populations are performed at baseline and at 12 month follow-up, with multidisciplinary investigative approach.
A mix of risk and predisposition factors should emerge combining the three groups of measures, in the two populations, along the two times of data collection.
- Conditions
- Diabetes Mellitus Foot Ulcer
- Being tested
- Full Analysis, Partial Analysis
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full AnalysisProcedure or surgery
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
Partial AnalysisProcedure or surgery
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
| Study group | Role | What they receive |
|---|---|---|
| Population 1 | Other | Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk. Receives: Procedure: Full Analysis |
| Population 2 | Other | Patients affected by diabetes mellitus type-2: typical adult subjects affected by diabetic foot, who had foot ulcers and thus in risk grade 3. The ulcerative lesions must have been resolved from at least 6 months, so that there is no longer acute inflammatory process in progress at the time of blood sampling. Receives: Procedure: Partial Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological biochemical analysis
Parameters related to the profile of blood biomarkers for inflammation will be acquired from samples collected for Population 1 and Population 2.
Measured: baseline, 12 months
Secondary outcomes (2)
Clinical - metabolical analysis
These evaluations will include the analysis of patients' medical history
Measured: baseline, 12 months
Functional analysis
Instrumental evaluations are collected from only Population 1
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start3 Nov 2025
- Primary completion15 Mar 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Foot UlcerStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- population 1 will be enrolled with no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); population 2 is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Maria Cecilia Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021222
- Sponsor's protocol ID
- DARE-DiaFoot
- Acronym
- DARE-DiaFoot
- Status last verified
- Jan 2026
- First submitted
- 27 May 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared until a full collection, analysis and major comprehension of the dataset by the scientists in the three centers involved; this dataset in fact is going to be very vast, very complex, and multi-disciplinary, and also the statistical analysis is expected to be difficult. These activities thus do deserve a careful scrutiny by the designers of the study before the dataset can be managed by other scientists; and this is going to take many years.
Publications
van Netten JJ, Raspovic A, Lavery LA, Monteiro-Soares M, Paton J, Rasmussen A, Sacco ICN, Bus SA. Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2024 Mar;40(3):e3652. doi: 10.1002/dmrr.3652. Epub 2023 May 27.
PubMed 37243880Senneville E, Albalawi Z, van Asten SA, Abbas ZG, Allison G, Aragon-Sanchez J, Embil JM, Lavery LA, Alhasan M, Oz O, Uckay I, Urbancic-Rovan V, Xu ZR, Peters EJG. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3687. doi: 10.1002/dmrr.3687. Epub 2023 Oct 1.
PubMed 37779323Leardini A, Benedetti MG, Berti L, Bettinelli D, Nativo R, Giannini S. Rear-foot, mid-foot and fore-foot motion during the stance phase of gait. Gait Posture. 2007 Mar;25(3):453-62. doi: 10.1016/j.gaitpost.2006.05.017. Epub 2006 Sep 11.
PubMed 16965916Ortolani M, Leardini A, Pavani C, Scicolone S, Girolami M, Bevoni R, Lullini G, Durante S, Berti L, Belvedere C. Angular and linear measurements of adult flexible flatfoot via weight-bearing CT scans and 3D bone reconstruction tools. Sci Rep. 2021 Aug 9;11(1):16139. doi: 10.1038/s41598-021-95708-x.
PubMed 34373546Leardini A, Pagotto U, Dalla Paola L, Leopardi MP, Belvedere C, Ortolani M, Platano D, Caravaggi P, Rogati G, Sacchetti G, Grimaldi MS, Casadei G, Lopreiato V, Tremoli E, Maffessanti F, Tenti E, Sangiorgi D, Ferroni L, Malagoni AM, Veglia F, Berti L. Multifactorial strategies for the prevention of the risks of ulceration in patients affected by diabetic foot: a no-profit, multicentre, clinical trial protocol. BMJ Open. 2026 Jun 19;16(6):e112163. doi: 10.1136/bmjopen-2025-112163.
PubMed 42320969
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
- ClinicalTrials.gov ID
- NCT07021222
- Acronym / sponsor ID
- DARE-DiaFoot / DARE-DiaFoot
- Conditions
- Diabetes Mellitus Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Maria Cecilia Hospital
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
Detailed description
This is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.
A first population has no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); a second population is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
One centre provides thorough biomechanical and functional analyses also based on modern Computed Tomography in weight-bearing; another centre performs state-of-the-art clinical assessments and metabolic analyses; the third centre performs the latter, together with advanced biological and biochemical analyses.
Comparisons of all these multi-instrumental measurements between the two populations are performed at baseline and at 12 month follow-up, with multidisciplinary investigative approach.
A mix of risk and predisposition factors should emerge combining the three groups of measures, in the two populations, along the two times of data collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- population 1 will be enrolled with no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); population 2 is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months.
| Arm | Type | Receives |
|---|---|---|
| Population 1 | Other | Procedure: Full AnalysisPatients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk. |
| Population 2 | Other | Procedure: Partial AnalysisPatients affected by diabetes mellitus type-2: typical adult subjects affected by diabetic foot, who had foot ulcers and thus in risk grade 3. The ulcerative lesions must have been resolved from at least 6 months, so that there is no longer acute inflammatory process in progress at the time of blood sampling. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full AnalysisPopulation 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses. | Procedure or surgery | Population 1 |
| Partial AnalysisPopulation 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses. | Procedure or surgery | Population 2 |
Primary outcome
Biological biochemical analysis
Time frame: baseline, 12 months
Parameters related to the profile of blood biomarkers for inflammation will be acquired from samples collected for Population 1 and Population 2.
2 secondary outcomes
Clinical - metabolical analysis
Time frame: baseline, 12 months
Functional analysis
Time frame: baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 37243880van Netten JJ, Raspovic A, Lavery LA, Monteiro-Soares M, Paton J, Rasmussen A, Sacco ICN, Bus SA. Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2024 Mar;40(3):e3652. doi: 10.1002/dmrr.3652. Epub 2023 May 27.
- Background: PubMed 37779323Senneville E, Albalawi Z, van Asten SA, Abbas ZG, Allison G, Aragon-Sanchez J, Embil JM, Lavery LA, Alhasan M, Oz O, Uckay I, Urbancic-Rovan V, Xu ZR, Peters EJG. IWGDF/IDSA guidelines on the diagnosis and treatment of diabetes-related foot infections (IWGDF/IDSA 2023). Diabetes Metab Res Rev. 2024 Mar;40(3):e3687. doi: 10.1002/dmrr.3687. Epub 2023 Oct 1.
- Background: PubMed 16965916Leardini A, Benedetti MG, Berti L, Bettinelli D, Nativo R, Giannini S. Rear-foot, mid-foot and fore-foot motion during the stance phase of gait. Gait Posture. 2007 Mar;25(3):453-62. doi: 10.1016/j.gaitpost.2006.05.017. Epub 2006 Sep 11.
- Background: PubMed 34373546Ortolani M, Leardini A, Pavani C, Scicolone S, Girolami M, Bevoni R, Lullini G, Durante S, Berti L, Belvedere C. Angular and linear measurements of adult flexible flatfoot via weight-bearing CT scans and 3D bone reconstruction tools. Sci Rep. 2021 Aug 9;11(1):16139. doi: 10.1038/s41598-021-95708-x.
- Derived from this study: PubMed 42320969Leardini A, Pagotto U, Dalla Paola L, Leopardi MP, Belvedere C, Ortolani M, Platano D, Caravaggi P, Rogati G, Sacchetti G, Grimaldi MS, Casadei G, Lopreiato V, Tremoli E, Maffessanti F, Tenti E, Sangiorgi D, Ferroni L, Malagoni AM, Veglia F, Berti L. Multifactorial strategies for the prevention of the risks of ulceration in patients affected by diabetic foot: a no-profit, multicentre, clinical trial protocol. BMJ Open. 2026 Jun 19;16(6):e112163. doi: 10.1136/bmjopen-2025-112163.
- Individual participant dataSharing planned: No. Data will not be shared until a full collection, analysis and major comprehension of the dataset by the scientists in the three centers involved; this dataset in fact is going to be very vast, very complex, and multi-disciplinary, and also the statistical analysis is expected to be difficult. These activities thus do deserve a careful scrutiny by the designers of the study before the dataset can be managed by other scientists; and this is going to take many years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Analysis and Partial Analysis in people with Diabetes Mellitus Foot Ulcer, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Berti, MD (051.63.66 ext. 197, lisa.berti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological biochemical analysis (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021222, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.