Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound

Condition(s) studied

Investigational drug(s) / intervention(s)

Amputation: Amputation was performed on diabetic foot ulcer

Debridement: Debridement of diabetic foot ulcers was performed

Study summary

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.

Eligibility

Primary outcome measure(s)

• H-CEUS score — 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.

Trial sites (1)

More First Affiliated Hospital of Wenzhou Medical University trials in China

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