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

NCT ID: NCT06309082

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

1. Investigate H-CEUS abnormalities in microcirculation at DFU ulcer sites Conduct H-CEUS detection of blood vessels at ulcer sites for each participant. Qualitatively and quantitatively analyze differences in contrast enhancement time, intensity, uniformity, direction, and vessel morphology among different patient groups based on time-intensity curves. Compare H-CEUS indicators between DFU ulcer and normal sites, followed by single-factor and multi-factor logistic regression analysis to identify meaningful imaging indicators for diagnosing DFU and construct an H-CEUS score.

2. Correlate H-CEUS score with traditional measurement indicators Perform color Doppler ultrasound (CDU), laser Doppler perfusion monitoring (LDPM), and transcutaneous partial pressure of oxygen (TcPO2) measurements at ulcer sites for participants. Analyze the correlation between H-CEUS score and the aforementioned five traditional microcirculation assessment methods. This analysis aims to determine if H-CEUS effectively reflects the degree of ischemia in DFU patients' ulcerated limbs, providing a new, non-invasive assessment tool to assist physicians in accurately assessing ulcer severity and tissue damage, facilitating the formulation of individualized and effective treatment plans.

3. Construct and evaluate the limb salvage predictive model using H-CEUS Conduct a retrospective analysis of clinical data from hospitalized DFU patients, categorizing them into limb salvage and amputation groups. Compare baseline data, biochemical indicators, and data based on H-CEUS scores between the two groups. Utilize single-factor and multi-factor logistic regression analysis to identify amputation-related risk factors. Subsequently, employ a random forest algorithm to construct a model based on H-CEUS data to predict limb salvage in DFU patients. To further validate the accuracy and clinical utility of this predictive model, nomogram charts and decision curve analysis (DCA) will be created.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic foot ulcer limb salvage group

The patient was treated without amputation

Debridement

Intervention Type: PROCEDURE

Debridement of diabetic foot ulcers was performed

Diabetic foot ulcer without limb salvage group

The treatment option for the patient was amputation

Amputation

Intervention Type: PROCEDURE

Amputation was performed on diabetic foot ulcer

Interventions

Amputation

Amputation was performed on diabetic foot ulcer

Intervention Type: PROCEDURE

Debridement

Debridement of diabetic foot ulcers was performed

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital the First Affiliated Hospital

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Shihao Xu, doctor

Role: CONTACT

dcxshvip@wmu.edu.cn

+86 13857766918

Facility Contacts

Shihao Xu

Role: primary

dcxshvip@wmu.edu.cn

13857766918

Other Identifiers

DFU

Identifier Type: -

Identifier Source: org_study_id