NCT07021222|Recruiting
Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)
DARE-DiaFoot
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DARE-DiaFoot
Sponsor study identifier
interventional
150
1 country
1
Study Start
November 3, 2025
Actual (reported)Primary Completion
March 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 27, 2025
Actual (reported)June 13, 2025
Actual (reported)November 3, 2025
Actual (reported)March 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
baseline, 12 months
Clinical - metabolical analysis
baseline, 12 months
Functional analysis
baseline, 12 months
Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk.
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.
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Istituto Ortopedico Rizzoli
Bologna, BO, 40136, Italy
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.
First Submitted
May 27, 2025
First Posted
June 13, 2025
Study Start
November 3, 2025
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Leardini 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.
Primary Completion
March 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 21, 2026
Record last verified: 2026-01
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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Source: ClinicalTrials.gov.
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