Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full Analysis, Partial Analysis.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Foot Ulcer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
Overview
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.
Interventions
- Procedure Full Analysis
Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses. - Procedure Partial Analysis
Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.
Primary outcome measures
- Biological biochemical analysis [Time frame: baseline, 12 months]
Secondary outcome measures (2)
- Clinical - metabolical analysis [Time frame: baseline, 12 months]
- Functional analysis [Time frame: baseline, 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
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. PMID 37243880
- 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. PMID 37779323
- 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. PMID 16965916
- 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. PMID 34373546
- 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 tri PMID 42320969
Identifiers
NCT: NCT07021222 · DARE-DiaFoot