NCT07021222

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Nov 2025May 2027

First Submitted

Initial submission to the registry

May 27, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

November 3, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

May 27, 2025

Last Update Submit

January 19, 2026

Conditions

Diabetes Mellitus Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Clinical - metabolical analysis

    baseline, 12 months

  • Functional analysis

    baseline, 12 months

Study Arms (2)

Population 1

OTHER

Patients affected by diabetes mellitus type-2 with no previous history of foot ulceration, but with a moderate ulcerative risk.

Procedure: Full Analysis

Population 2

OTHER

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.

Procedure: Partial Analysis

Interventions

Full AnalysisPROCEDURE

Population 1 receives all three groups of analyses:Clinical-metabolical analyses, Biological-biochemical analyses, and Biomechanical-functional analyses.

Population 1
Partial AnalysisPROCEDURE

Population 2 receives two groups of analyses:Clinical-metabolical analyses and Biological-biochemical analyses.

Population 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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
  • Infections in progress, ongoing neoplasms
  • Immunosuppressive therapies, and cortisone-based therapy
  • Pregnancy and lactation
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

RECRUITING

Related Publications (4)

  • 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: 37243880BACKGROUND

  • 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: 37779323BACKGROUND

  • 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: 16965916BACKGROUND

  • 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: 34373546BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

Lisa Berti, MD

CONTACT

051.63.66lisa.berti@ior.it

Alberto Leardini, DPHIL

CONTACT

051.63.66alberto.leardini@ior.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 13, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

IT(1)