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

NCT06309082 | Not Yet Recruiting DMC

• 1 other identifier: DFU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetic Foot Ulcers; High-Frequency Contrast-Enhanced Ultrasound; Microcirculation blood supply assessment; Amputation; Limb salvage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diabetic foot ulcer limb salvage group

The patient was treated without amputation

Procedure: Debridement

Diabetic foot ulcer without limb salvage group

The treatment option for the patient was amputation

Procedure: Amputation

Interventions

Amputation PROCEDURE

Amputation was performed on diabetic foot ulcer

Diabetic foot ulcer without limb salvage group

Debridement PROCEDURE

Debridement of diabetic foot ulcers was performed

Diabetic foot ulcer limb salvage group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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\&amp;#39;s health.

You may qualify if:

• Patients meet the diagnosis criteria for diabetes
• They exhibit concurrent peripheral neuropathy and/or lower limb vascular lesions
• The feet show varying degrees of infection, ulcers, and/or damage to deep tissues

You may not qualify if:

• Other causes of inflammatory skin reactions (such as trauma, gout, acute neuropathic arthropathy, fibular fracture, thrombosis, venous congestion)
• Diabetes complicated by stasis dermatitis
• Use of medications or substances affecting vascular conditions, such as vasoconstrictors

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospital the First Affiliated Hospital

Wenzhou, Zhejiang, 325006, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Interventions

Amputation, Surgical; Debridement

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Central Study Contacts

Shihao Xu, doctor

CONTACT

+86 13857766918; dcxshvip@wmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)