Using dynamic 4D-CT imaging to measure the blood flow in the arteries and muscles to evaluate wounds in diabetic feet

ISRCTN	ISRCTN95737449
DOI	https://doi.org/10.1186/ISRCTN95737449
Secondary identifying numbers	DFPCT_V1

Submission date: 13/03/2023
Registration date: 14/03/2023
Last edited: 15/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Critical limb ischemia is a serious condition in people with diabetes that can lead to death or amputation. Doctors use a procedure called intra-arterial digital subtraction angiography (IADSA) to decide the best way to restore blood flow, but this method has limitations. This study aims to use a new technique called dynamic 4D-CT imaging with a small amount of contrast dye to measure blood flow and tissue health in the foot.

Who can participate?
Patients from the diabetic foot clinic with suspected critical limb ischemia referred for clinical IADSA as part of their vascular workup.

What does the study involve?
The participants receive a low-volume (2 mL) intra-arterial 4D contrast CT examination combined with a diagnostic IADSA examination.

What are the possible benefits and risks of participating?
The 4D-CT scans might provide additional hemodyanmic information which could be used by the vascular surgeon to optimize treatment planning. The minimal usage of contrast agent (2 mL) ensures low risks related to contrast media (nausea, headache, kidney damage). The estimated effective dose (<1 mSv, ICRP-103) is lower than the natural background radiation.

Where is the study run from?
Vrije Universiteit Brussel (Belgium)

When is the study starting and how long is it expected to run for?
March 2019 to February 2023

Who is funding the study?
Fonds Wetenschappelijk Onderzoek (Flemish Research Foundation) (Belgium)

Who is the main contact?
Pieter Thomas Boonen (pieter.thomas.boonen@vub.be)

Contact information

Mr Pieter Boonen
Scientific

Laarbeeklaan 101
Brussels
1090
Belgium

ORCID ID	0000-0003-4775-8620
Email	pieter.thomas.boonen@vub.be

Study information

Study design	Single-center observational study
Primary study design	Observational
Secondary study design	Prospective case report
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Combined evaluation of blood flow and tissue perfusion in diabetic feet by contrast-enhanced 4D-CT imaging
Study acronym	DFPCT
Study objectives	The advent of wide beam CT scanners allow to perform multiple CT acquisitions over the same structure at a high frame rate, enabling to obtain dynamic CTA data. Potential benefits of such dynamic series can be identified as morphological, hemodynamic, and functional. This study aims at exploiting these dynamic acquisitions for improved anatomic and hemodynamic information in patients with foot ulcers by assessing the arterial blood flow and tissue perfusion low-volume contrast injections. This could lead to a new method for optimized treatment planning.
Ethics approval(s)	Approved 20/03/2019, Medical Ethics Committee UZ Brussel (Laarbeeklaan 101, 1090 Brussels, Belgium; +32 2 477 55 85; ethiek@uzbrussel.be), ref: B.U.N. 143201939233/I/U
Health condition(s) or problem(s) studied	Assessment of critical limb ischemia in patients with diabetes
Intervention	Patients with diabetic foot and a high suspicion of critical limb ischemia (CLI) receive a diagnostic IADSA examination as part of their vascular workup at the diabetic foot clinic. In addition, the patients receive a low-volume (2 mL) intra-arterial 4D contrast CT examination using a combined CTA and CTP protocol consisting of multiple 160 mm axial series at different interphase delays for a total duration of 194s. Foot ulcers and stenoses are assessed by the vascular surgeon using the IADSA data to plan the treatment.
Intervention type	Other
Primary outcome measure	Arterial blood flow and tissue perfusion are quantified voxel-wise from 4D-CT data using 2mL of contrast agent at a single time point
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	20/03/2019
Completion date	01/02/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	3
Key inclusion criteria	1. Diabetic foot 2. Suspicion of critical limb ischemia 3. Referred for IADSA
Key exclusion criteria	1. Known allergic reactions to iodinated contrast agents 2. Hyperthyroidism 3. Dialysis
Date of first enrolment	01/01/2021
Date of final enrolment	01/08/2021

Locations

Countries of recruitment

Belgium

Study participating centre

UZ Brussel

Laarbeeklaan 101
Brussels
1090
Belgium

Sponsor information

Vrije Universiteit Brussel
University/education

Pleinlaan 2
Brussels
1050
Belgium

Phone	+32 2 629 20 10
Email	RD.secretariaat@vub.be
Website	http://www.vub.ac.be/en/
"ROR"	https://ror.org/006e5kg04

Funders

Funder type

Government

Fonds Wetenschappelijk Onderzoek
Government organisation / Local government

Alternative name(s): Research Foundation Flanders, Flemish Research Foundation, FWO
Location: Belgium

Results and Publications

Intention to publish date	01/09/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication of case-report in a high-impact peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/07/2023	26/07/2023	Yes	No

Editorial Notes

15/09/2023: Internal review.
26/07/2023: Publication reference added.
13/03/2023: Trial's existence confirmed by Medical Ethics Committee UZ Brussel.