NCT06725238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 4, 2024

Last Update Submit

December 7, 2024

Conditions

Keywords

Diabetes foot ulcersAcute-to-chronic glycemic indexLeucocyte-glucose indexTriglyceride-glucose index

Outcome Measures

Primary Outcomes (1)

  • Acute-to-chronic glycemic ratio

    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.

    The measurement is done at the time of recruitment

Secondary Outcomes (1)

  • Leucocyte-glucose index

    at the time of recruitment

Study Arms (2)

Group I : patients presented with DFUs.

Participants who were referred to the consultant clinics at the Shar hospital were included if they had (i) a history of T2D irrespective of antidiabetic medicines or (ii) clinical and laboratory evidence of diabetic foot ulcers.

Other: Acute-to-chronic glycemic ratio

Group II: patients who had T2D without DFUs

The participants have no previous history of diabetic foot ulcer or amputation. There were managed with oral anti-diabetes or occasionally with short term insulin therapy

Interventions

This ratio could be related to diabetic foot ulcer

Also known as: Leucocyte glucose index, Triglyceride-glucose index
Group I : patients presented with DFUs.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic participants with or without diabetic foot ulcer who were referred to the consultant clinics at the Shar hospital in Sulaymaniyah, Iraq were recruited

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, University of Diyala

Baqubah, Diyala Governorate, 32001, Iraq

Location

Related Publications (1)

  • Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.

    PMID: 37395769BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Rawa A Ratha, M.Sc., PhD

    College of Pharmacy, University of Sulaimani, Sulaymaniyah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Pharmacology and Therapeutics

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 10, 2024

Study Start

May 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 10, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations