Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)

Официальное название

Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Full Analysis
  Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.
• Процедура Partial Analysis
  Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.

Первичные конечные точки

• Biological biochemical analysis [Срок оценки: baseline, 12 months]

Вторичные конечные точки (2)

• Clinical - metabolical analysis [Срок оценки: baseline, 12 months]
• Functional analysis [Срок оценки: baseline, 12 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• 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

Идентификаторы

NCT: NCT07021222 · DARE-DiaFoot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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