the First Affiliated Hospital the First Affiliated Hospital
Wenzhou, Zhejiang, 325006, China
NCT Number: NCT06309082
The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows:
* What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging? * Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds.
Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds.
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Observational
Wenzhou, Zhejiang, 325006, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Amputation was performed on diabetic foot ulcer
Debridement of diabetic foot ulcers was performed
Time frame: baseline, pre-intervention
Establishment of the H-CEUS Score: Single-factor and multi-factor logistic regression analyses will be performed on parameters obtained from H-CEUS. H-CEUS candidate parameters with statistically significant values (p < 0.05) will be selected. Finally, the diagnostic model's H-CEUS scoring formula will be built using the identified indicators. The H-CEUS score is calculated as follows: H-CEUS Score = val(Parameter1) * β1 + val(Parameter2) * β2 + ⋯ + val(Parameter n) * βn + Intercept Value. Here, "val" represents the CEUS parameter value, and "β" represents the regression coefficient.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Wenzhou Medical University
Other
Application of High-frequency Contrast-enhanced Ultrasound in Visual Evaluation of Microcirculation in Diabetic Foot Ulcers
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