First Affiliated Hospital of Wenzhou Medical University
Phase
Observational
Started
2024-11
Last updated
2024-10-29
Condition(s) studied
Diabetes Mellitus
Investigational drug(s) / intervention(s)
AmputationDebridement
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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients meet the diagnosis criteria for diabetes
2. They exhibit concurrent peripheral neuropathy and/or lower limb vascular lesions
3. The feet show varying degrees of infection, ulcers, and/or damage to deep tissues
Exclusion Criteria:
1. Other causes of inflammatory skin reactions (such as trauma, gout, acute neuropathic arthropathy, fibular fracture, thrombosis, venous congestion)
2. Exclusion of patients with impaired fasting glucose and abnormal glucose tolerance
3. Diabetes complicated by stasis dermatitis
4. Use of medications or substances affecting vascular conditions, such as vasoconstrictors
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)
Facility
City
Region
Status
the First Affiliated Hospital the First Affiliated Hospital
Wenzhou
Zhejiang
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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