Diabetic Foot Ulcer (DFU)ACGRNCT06725238
Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .
An observational study of Diabetic Foot Ulcer (DFU), run by University of Diyala at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU)
- What is being tested?
- Acute-to-chronic glycemic ratio
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 May 2024to 10 Nov 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin
Who cannot join
- History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.
- -
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of Medicine, University of Diyala
Baqubah, Diyala Governorate, 32001
About this study
Official title: The Interplay of Acute-to-Chronic Glycemic Ratio With Other Biomarkers in Diabetic Foot Ulcers: An Effect is Not Related to the Therapeutic Remedies
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer (DFU)
- Being tested
- Acute-to-chronic glycemic ratio
- Keywords
- Diabetes foot ulcers, Acute-to-chronic glycemic index, Leucocyte-glucose index, Triglyceride-glucose index
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute-to-chronic glycemic ratioOther
Also called Leucocyte glucose index, Triglyceride-glucose index
This ratio could be related to diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The measurement is done at the time of recruitment
Secondary outcomes (1)
Leucocyte-glucose index
Leukocyte-glucose index (LGI) combines total leukocyte and plasma glucose levels, which could serve as a prognostic biomarker of DFUs.
Measured: at the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 May 2024
- Primary completion1 Nov 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- University of Diyala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Salih Mohamad Al-Nimer, University of Diyala
- Investigators
- Rawa A Ratha, M.Sc., PhD, Principal investigator, College of Pharmacy, University of Sulaimani, Sulaymaniyah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725238
- Sponsor's protocol ID
- PH130-24
- Other IDs
- University of Sulaimani
- Acronym
- ACGR
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37395769
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interplay of Acute-to-Chronic Glycemic Ratio With Other Biomarkers in Diabetic Foot Ulcers: An Effect is Not Related to the Therapeutic Remedies
- ClinicalTrials.gov ID
- NCT06725238
- Acronym / sponsor ID
- ACGR / PH130-24
- Conditions
- Diabetic Foot Ulcer (DFU)
- Keywords
- Diabetes foot ulcers, Acute-to-chronic glycemic index, Leucocyte-glucose index, Triglyceride-glucose index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of DiyalaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I : patients presented with DFUs. | – | Other: Acute-to-chronic glycemic ratioParticipants 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. |
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin
Key exclusion criteria (2 listed)
- History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute-to-chronic glycemic ratioAlso: Leucocyte glucose index, Triglyceride-glucose indexThis ratio could be related to diabetic foot ulcer | Other | Group I : patients presented with DFUs. |
Primary outcome
Acute-to-chronic glycemic ratio
Time frame: 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.
1 secondary outcome
Leucocyte-glucose index
Time frame: at the time of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 37395769Armstrong 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.
- An article was studied the benefit of determination the stress hyperglycemiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rawa A Ratha, M.Sc., PhD principal investigator
College of Pharmacy, University of Sulaimani, Sulaymaniyah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU), run by University of Diyala at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute-to-chronic glycemic ratio (time frame: The measurement is done at the time of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06725238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.