Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)
NCT ID: NCT07021222
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2026-09-01
2026-12-15
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Population 2
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.
Partial Analysis
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Population 1
Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk.
Full Analysis
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
Interventions
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Full Analysis
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
Partial Analysis
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Infections in progress, ongoing neoplasms
* Immunosuppressive therapies, and cortisone-based therapy
* Pregnancy and lactation
* Inability to provide informed consent
* Infections in progress, ongoing neoplasms
* Immunosuppressive therapies, and cortisone-based therapy
* Pregnancy and lactation
* Inability to provide informed consent
18 Years
75 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Maria Cecilia Hospital
OTHER
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Central Contacts
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References
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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.
Senneville 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.
Leardini 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.
Ortolani 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.
Other Identifiers
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DARE-DiaFoot
Identifier Type: -
Identifier Source: org_study_id