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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Diabetic Foot Ulcers (DFU)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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diabetic foot ulcer

Diabetic Patients with DFU, who were diagnosed by a vascular surgeon based on Diabetic Foot Study Group guidelines.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amal Refaie Ahmed Ali

resident doctor Assiut University hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amal Refaie Ahmed Ali, resident doctor

Role: CONTACT

Phone: +2 01151217881

Email: [email protected]

References

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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.

Reference Type RESULT

PMID: 38174781 (View on PubMed)

Other Identifiers

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LVF strain echocardiography

Identifier Type: -

Identifier Source: org_study_id