Diabetic Foot Ulcers (DFU)NCT06747377
Evaluation of Left Ventricular Function After Treatment of Diabetic Foot Ulcers Using Longitudinal Strain Echocardiography
An observational study of Diabetic Foot Ulcers (DFU), run by Assiut University.
Trial summary
Early detection of heart failure as a macrovascular complication of DM offers the best chance of cure in these patients. Nowadays, the most common method for detecting heart failure is measuring left ventricle ejection fraction (LV-EF), by echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers (DFU)
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Group guidelines. -Diabetic Patients were who used anti-diabetic oral medication, insulin or who had fasting blood glucose (FBS) ≥ 126 mg/dl for at least two times at age group 18 to 50 years at Assiut university hospital
Who may be able to join
- Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines.
- Diabetic Patients were who used anti-diabetic oral medication, insulin or who had fasting blood glucose (FBS) ≥ 126 mg/dl for at least two times at age group 18 to 50 years at Assiut university hospital
Who cannot join
- Patients with acute or advanced stage of renal, hepatic or pulmonary diseases, acute coronary syndrome, known coronary artery disease ,infectious disease in the last two weeks, coagulopathy, history of a hemorrhagic stroke, severe valvular disease , heart failure (EF<45%).
- at age group below 18 or above 50 years old.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Early detection of heart failure as a macrovascular complication of DM offers the best chance of cure in these patients. Nowadays, the most common method for detecting heart failure is measuring left ventricle ejection fraction (LV-EF), by echocardiography. Despite the easy application of LV-EF, it remains normal in early stages of cardiac disease and it's considered as heart failure with preserved LVEF (HFpEF). We hope that, Strain monitoring as a new method enables us to detect the early minimal changes in myocardium.
The aim of study evaluate the effect of treatment of diabetic foot ulcers in improving heart function by strain echocardiography than conventional transthoracic echocardiography in Assiut university hospital.
Read the detailed description
Diabetes mellitus (DM) is a chronic, metabolic disease with hyperglycemia that occurs as a result of deficiency or resistance of insulin hormone secreted from the pancreas. Diabetic foot ulcer (DFU)is a frequent macrovascular complication has a high incidence and mortality rate. According to research statistics, the mortality rate of patients with foot ulcers after 5 years is 2.5 times higher than that of patients without such ulcers. Heart failure develops in diabetic patients over twice higher than non-diabetics both directly, by impairing cardiac function, and indirectly, through associated diseases such as hypertension, coronary disease, renal dysfunction, obesity, and other metabolic disorders.
Based on a recent study, DFU treatment improves cardiac function assessed by strain measurements . At present, few data is available about the ability of strain echocardiography in prediction of systolic dysfunction in DFU, and the possible effect of the treatment of these patients on their cardiac function. So, we decided to evaluate the effect of treatment of diabetic foot ulcers in improving heart function by this new method-strain echocardiography.
- Conditions
- Diabetic Foot Ulcers (DFU)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetic foot ulcer | Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
cure rate after Diabetic foot ulcers treatment in patients who suffer from this condition can lead to an improvement in cardiac function,
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcers (DFU)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Refaie Ahmed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747377
- Sponsor's protocol ID
- LVF strain echocardiography
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jin Y, Meng M, Zhang Y, Mo L, Gao H, Liu Y, Wu J, Yang P, Zhang Z, Jia F, Zhao Y, Huang Y. Comparative study on the efficacy of PRP gel and UC-MSCs gel as adjuvant therapies in the treatment of DFU wounds. Skin Res Technol. 2024 Jan;30(1):e13549. doi: 10.1111/srt.13549.
PubMed 38174781
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Function After Treatment of Diabetic Foot Ulcers Using Longitudinal Strain Echocardiography
- ClinicalTrials.gov ID
- NCT06747377
- Acronym / sponsor ID
- LVF strain echocardiography
- Conditions
- Diabetic Foot Ulcers (DFU)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Dec 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.
Early detection of heart failure as a macrovascular complication of DM offers the best chance of cure in these patients. Nowadays, the most common method for detecting heart failure is measuring left ventricle ejection fraction (LV-EF), by echocardiography. Despite the easy application of LV-EF, it remains normal in early stages of cardiac disease and it's considered as heart failure with preserved LVEF (HFpEF). We hope that, Strain monitoring as a new method enables us to detect the early minimal changes in myocardium.
The aim of study evaluate the effect of treatment of diabetic foot ulcers in improving heart function by strain echocardiography than conventional transthoracic echocardiography in Assiut university hospital.
Detailed description
Diabetes mellitus (DM) is a chronic, metabolic disease with hyperglycemia that occurs as a result of deficiency or resistance of insulin hormone secreted from the pancreas. Diabetic foot ulcer (DFU)is a frequent macrovascular complication has a high incidence and mortality rate. According to research statistics, the mortality rate of patients with foot ulcers after 5 years is 2.5 times higher than that of patients without such ulcers. Heart failure develops in diabetic patients over twice higher than non-diabetics both directly, by impairing cardiac function, and indirectly, through associated diseases such as hypertension, coronary disease, renal dysfunction, obesity, and other metabolic disorders.
Based on a recent study, DFU treatment improves cardiac function assessed by strain measurements . At present, few data is available about the ability of strain echocardiography in prediction of systolic dysfunction in DFU, and the possible effect of the treatment of these patients on their cardiac function. So, we decided to evaluate the effect of treatment of diabetic foot ulcers in improving heart function by this new method-strain echocardiography.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetic foot ulcer | – | –Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Group guidelines. -Diabetic Patients were who used anti-diabetic oral medication, insulin or who had fasting blood glucose (FBS) ≥ 126 mg/dl for at least two times at age group 18 to 50 years at Assiut university hospital
Key inclusion criteria (2 listed)
- Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines.
- Diabetic Patients were who used anti-diabetic oral medication, insulin or who had fasting blood glucose (FBS) ≥ 126 mg/dl for at least two times at age group 18 to 50 years at Assiut university hospital
Key exclusion criteria (2 listed)
- Patients with acute or advanced stage of renal, hepatic or pulmonary diseases, acute coronary syndrome, known coronary artery disease ,infectious disease in the last two weeks, coagulopathy, history of a hemorrhagic stroke, severe valvular disease , heart failure (EF<45%).
- at age group below 18 or above 50 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cure rate
Time frame: baseline
cure rate after Diabetic foot ulcers treatment in patients who suffer from this condition can lead to an improvement in cardiac function,
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 24 Dec 2024.
- Results publication: PubMed 38174781Jin Y, Meng M, Zhang Y, Mo L, Gao H, Liu Y, Wu J, Yang P, Zhang Z, Jia F, Zhao Y, Huang Y. Comparative study on the efficacy of PRP gel and UC-MSCs gel as adjuvant therapies in the treatment of DFU wounds. Skin Res Technol. 2024 Jan;30(1):e13549. doi: 10.1111/srt.13549.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcers (DFU), run by Assiut University.
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 2 inclusion and 2 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Amal Refaie Ahmed Ali, resident doctor (+2 01151217881, amalrefaie392@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747377, which also lists 1 linked publication.
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 24 Dec 2024.