Evaluation of Left Ventricular Function After Treatment of Diabetic Foot Ulcers Using Longitudinal Strain Echocardiography

December 20, 2024 updated by: Amal Refaie Ahmed Ali, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
diabetic foot ulcer
Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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,
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LVF strain echocardiography

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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