Clinical trial NCT07021222: Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaFoot)
Official title: Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Foot Ulcer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria Cecilia Hospital
First posted: 2025-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

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

Primary outcomes:
measure: Biological biochemical analysis
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Clinical - metabolical analysis
timeFrame: baseline, 12 months
measure: Functional analysis
timeFrame: baseline, 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.