Diabetes MellitusNCT06309082
Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound
An observational study of Diabetes Mellitus, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Amputation and Debridement
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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\'s health.
Who may be able to join
- 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
Who cannot join
- Other causes of inflammatory skin reactions (such as trauma, gout, acute neuropathic arthropathy, fibular fracture, thrombosis, venous congestion)
- Exclusion of patients with impaired fasting glucose and abnormal glucose tolerance
- Diabetes complicated by stasis dermatitis
- Use of medications or substances affecting vascular conditions, such as vasoconstrictors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital the First Affiliated Hospital
Wenzhou, Zhejiang, 325006
Shihao Xu, 13857766918, dcxshvip@wmu.edu.cn
Shihao Xu
About this study
Official title: Application of High-frequency Contrast-enhanced Ultrasound in Visual Evaluation of Microcirculation in Diabetic Foot Ulcers
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.
Read the detailed description
- 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.
- 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.
- 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
- Being tested
- Amputation, Debridement
- Keywords
- Diabetic Foot Ulcers, High-Frequency Contrast-Enhanced Ultrasound, Microcirculation blood supply assessment, Amputation, Limb salvage
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmputationProcedure or surgery
Amputation was performed on diabetic foot ulcer
DebridementProcedure or surgery
Debridement of diabetic foot ulcers was performed
| Study group | Role | What they receive |
|---|---|---|
| Diabetic foot ulcer limb salvage group | The patient was treated without amputation Receives: Procedure: Debridement | |
| Diabetic foot ulcer without limb salvage group | The treatment option for the patient was amputation Receives: Procedure: Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309082
- Sponsor's protocol ID
- DFU
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High-frequency Contrast-enhanced Ultrasound in Visual Evaluation of Microcirculation in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06309082
- Acronym / sponsor ID
- DFU
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetic Foot Ulcers, High-Frequency Contrast-Enhanced Ultrasound, Microcirculation blood supply assessment, Amputation, Limb salvage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic foot ulcer limb salvage group | – | Procedure: DebridementThe patient was treated without amputation |
| Diabetic foot ulcer without limb salvage group | – | Procedure: AmputationThe treatment option for the patient was amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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\&#39;s health.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Other causes of inflammatory skin reactions (such as trauma, gout, acute neuropathic arthropathy, fibular fracture, thrombosis, venous congestion)
- Exclusion of patients with impaired fasting glucose and abnormal glucose tolerance
- Diabetes complicated by stasis dermatitis
- Use of medications or substances affecting vascular conditions, such as vasoconstrictors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmputationAmputation was performed on diabetic foot ulcer | Procedure or surgery | Diabetic foot ulcer without limb salvage group |
| DebridementDebridement of diabetic foot ulcers was performed | Procedure or surgery | Diabetic foot ulcer limb salvage group |
Primary outcome
H-CEUS score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shihao Xu, doctor (+86 13857766918, dcxshvip@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-CEUS score (time frame: baseline, pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.