An observational study in Diabetes Mellitus, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Observational
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:
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 186 observational studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diabetes is the second most common chronic disease, following hypertension. Diabetic foot ulcers are a prevalent and severe complication among diabetic patients, resulting from peripheral neuropathy or vascular lesions caused by thickening of the arterial walls and narrowing of the lumen in the lower limbs. This condition can lead to foot infections, ulcers, or deep tissue damage. In the early stages of the disease, patients may not perceive any noticeable changes, experiencing occasional walking pain in the feet. Without proper attention, this can progress to ulcers, difficulty in walking, and even gangrene, causing necrosis of muscles and bone tissues. In severe cases, it may lead to amputation, posing a significant threat to the patient\'s health.
Exclusion Criteria:
The patient was treated without amputation
Procedure: Debridement
The treatment option for the patient was amputation
Procedure: Amputation
Amputation was performed on diabetic foot ulcer
Debridement of diabetic foot ulcers was performed
H-CEUS score
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.
Time frame: baseline, pre-intervention
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Wenzhou Medical University