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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic foot ulcer limb salvage group | The patient was treated without amputation |
| |
| Diabetic foot ulcer without limb salvage group | The treatment option for the patient was amputation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amputation | Procedure | Amputation was performed on diabetic foot ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, pre-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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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&#39;s health.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shihao Xu, doctor | Contact | +86 13857766918 | dcxshvip@wmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital the First Affiliated Hospital | Wenzhou | Zhejiang | 325006 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000671 | Amputation, Surgical |
| D003646 | Debridement |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Debridement | Procedure | Debridement of diabetic foot ulcers was performed |
|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |