Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .

Completed

• Conditions: Diabetic Foot Ulcer (DFU)

• Registration Number: NCT06725238
• Lead Sponsor: University of Diyala

Brief Summary

Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities. Uncontrolled glycemic status and significantly higher glycosylated hemoglobin (HbA1c) are associated with DFUs. This study aimed to assess the acute-to-chronic glycemic ratio (ACGR) in type 2 diabetes (T2D) with DFUs and compare it with those without DFUs, considering the relationships of this ratio with other indices that characterized the pathogenesis of T2D. This cross-sectional study was conducted on T2D with DFUs and non-DFUs. The primary outcome is ACGR. The secondary outcomes are indices related to the anthropometric, metabolic, and hematological variables.

Detailed Description

DFUs are a macrovascular complication of diabetes mellitus resulting from peripheral artery disease and peripheral neuropathy that commonly affects the lower extremities. The DFUs are usually classified and scored according to the clinical findings. The ACGR is computed by dividing the acute (or current, or on admission in hospital) plasma glucose level by the chronic plasma glucose level calculated using the current (or on admission) HbA1c value.

Study Timeline

• Study Start: 2024-05-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin

Exclusion Criteria

History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute-to-chronic glycemic ratio	The measurement is done at the time of recruitment	The glycemic index represents the current or acute level of fasting plasma glucose and the HbA1c, which indicates the chronic glycemic status, is elevated in DFUs. The chronic plasma glucose level could be determined by using the equation of 28.7 × HbA1c (%) - 46.7.

Secondary Outcome Measures

Name	Time	Method
Leucocyte-glucose index	at the time of recruitment	Leukocyte-glucose index (LGI) combines total leukocyte and plasma glucose levels, which could serve as a prognostic biomarker of DFUs.

Trial Locations

Locations (1)

College of Medicine, University of Diyala; 🇮🇶 Baqubah, Diyala, Iraq