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Not yet recruitingNCT06747377Updated Dec 24, 2024

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

An observational study in Diabetic Foot Ulcers (DFU), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Diabetic Foot Ulcers (DFU)

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03

In context

Diabetic Foot

1,077 studies on the registry are indexed under Diabetic Foot; 224 are open to participants now.

This study's planned enrollment of 52 is below the median of 100 across 190 observational studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • diabetic foot ulcer

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

06

What researchers measure

Primary outcomes

  1. cure rate

    cure rate after Diabetic foot ulcers treatment in patients who suffer from this condition can lead to an improvement in cardiac function,

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06747377
Lead sponsor
Assiut University
Responsible party
Amal Refaie Ahmed Ali (resident doctor Assiut University hospital, Assiut University) — Principal investigator
First posted
Dec 24, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Dec 24, 2024

Study contacts

Amal Refaie Ahmed Ali, resident doctor
Contact
amalrefaie392@gmail.com
+2 01151217881

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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