Diabetic Foot UlcerNCT07188337
Characteristics of Diabetic Foot Ulcer Patients
An observational study of Diabetic Foot Ulcer and Diabetes Complications, run by Golestan University of Medical sciences at 1 site in Iran.
Trial summary
This study examines the demographic, clinical, and laboratory characteristics of patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, in 2024. By analyzing factors such as Hb, WBC, HbA1C, ESR, and CRP in relation to ulcer severity, the study aims to identify predictors of outcomes and support more… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes Complications
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- 27 Jul 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population will consist of approximately 200 patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, during 2024. Patients will be identified retrospectively from hospital medical records. Both demographic and clinical data, as well as laboratory findings, will be extracted for analysis
Who may be able to join
- Patients admitted to 5 Azar Hospital, Gorgan, in 2024
- Diagnosis of diabetic foot ulcer (DFU) confirmed by medical records
- Complete demographic, clinical, and laboratory data available in medical files
Who cannot join
- Incomplete or missing medical records
- Patients with foot ulcers of non-diabetic etiology
- Patients whose key laboratory data are unavailable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
5Th Azar Medical Center
Gorgan, Outside of the US, 4917956808
Pezhman Kharazm, MD, 09111751861 ext. 0098, pezhmankh@goums.ac.ir
About this study
Official title: Examining the Demographic, Clinical, and Laboratory Data of Patients With Diabetic Foot Ulcers Admitted to 5 Azar Hospital in 2024 (Registry Project)
This study examines the demographic, clinical, and laboratory characteristics of patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, in 2024. By analyzing factors such as Hb, WBC, HbA1C, ESR, and CRP in relation to ulcer severity, the study aims to identify predictors of outcomes and support more effective prevention and management strategies
Read the detailed description
Diabetic foot ulcer (DFU) is one of the most serious and preventable complications in diabetic patients, often leading to infection, hospitalization, lower limb amputation, and increased mortality. This cross-sectional descriptive-analytical study aims to investigate the demographic, clinical, and laboratory characteristics of approximately 200 patients with DFU admitted to 5 Azar Hospital, Gorgan, in 2024. Data will be retrospectively collected from medical records after obtaining ethical approval.
The study will analyze relationships between patient demographics, clinical features, and laboratory findings (including Hb, WBC, HbA1C, ESR, CRP) with ulcer severity based on Wagner's classification. Statistical tests such as independent t-test, chi-square, Fisher's exact test, and multivariable logistic regression will be used.
By identifying key factors associated with ulcer severity and outcomes, the findings of this study may contribute to more effective prevention and management strategies for diabetic foot ulcers, ultimately reducing complications and healthcare costs
- Conditions
- Diabetic Foot Ulcer, Diabetes Complications
- Keywords
- diabetic foot ulcer, diabetes mellitus, amputation, neuropathy
- Medical subject headings
- Diabetic Foot, Diabetes Complications, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of diabetic foot ulcer (measured by Wagner classification at admission)
Measured by Wagner classification
Measured: Baseline
Laboratory parameters and ulcer grade
Association between Hb, WBC, HbA1C, ESR, and CRP levels with Wagner ulcer grade
Measured: Baseline
Secondary outcomes (5)
Duration of diabetes until ulcer onset
Time (in years) between diabetes diagnosis and first DFU occurrence
Measured: Baseline
Smoking status and ulcer severity
Correlation between smoking history (yes/no) and Wagner ulcer grade
Measured: Baseline
Treatment outcomes
Frequency of outcomes: antibiotic therapy, wound debridement, or amputation
Measured: At hospital discharge (average of 10 days)
Ulcer recurrence
Number of hospital readmissions due to DFU.
Measured: During 12-month follow-up (based on records)
Demographic distribution
Age, sex, occupation, and ethnicity of DFU patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start27 Jul 2025
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pezhman Kharazm, MD, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188337
- Sponsor's protocol ID
- 114627
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Demographic, Clinical, and Laboratory Data of Patients With Diabetic Foot Ulcers Admitted to 5 Azar Hospital in 2024 (Registry Project)
- ClinicalTrials.gov ID
- NCT07188337
- Acronym / sponsor ID
- 114627
- Conditions
- Diabetic Foot Ulcer, Diabetes Complications
- Keywords
- diabetic foot ulcer, diabetes mellitus, amputation, neuropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 23 Sep 2025 (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.
This study examines the demographic, clinical, and laboratory characteristics of patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, in 2024. By analyzing factors such as Hb, WBC, HbA1C, ESR, and CRP in relation to ulcer severity, the study aims to identify predictors of outcomes and support more effective prevention and management strategies
Detailed description
Diabetic foot ulcer (DFU) is one of the most serious and preventable complications in diabetic patients, often leading to infection, hospitalization, lower limb amputation, and increased mortality. This cross-sectional descriptive-analytical study aims to investigate the demographic, clinical, and laboratory characteristics of approximately 200 patients with DFU admitted to 5 Azar Hospital, Gorgan, in 2024. Data will be retrospectively collected from medical records after obtaining ethical approval.
The study will analyze relationships between patient demographics, clinical features, and laboratory findings (including Hb, WBC, HbA1C, ESR, CRP) with ulcer severity based on Wagner's classification. Statistical tests such as independent t-test, chi-square, Fisher's exact test, and multivariable logistic regression will be used.
By identifying key factors associated with ulcer severity and outcomes, the findings of this study may contribute to more effective prevention and management strategies for diabetic foot ulcers, ultimately reducing complications and healthcare costs
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of approximately 200 patients with diabetic foot ulcers admitted to 5 Azar Hospital, Gorgan, during 2024. Patients will be identified retrospectively from hospital medical records. Both demographic and clinical data, as well as laboratory findings, will be extracted for analysis
Key inclusion criteria (3 listed)
- Patients admitted to 5 Azar Hospital, Gorgan, in 2024
- Diagnosis of diabetic foot ulcer (DFU) confirmed by medical records
- Complete demographic, clinical, and laboratory data available in medical files
Key exclusion criteria (3 listed)
- Incomplete or missing medical records
- Patients with foot ulcers of non-diabetic etiology
- Patients whose key laboratory data are unavailable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of diabetic foot ulcer (measured by Wagner classification at admission)
Time frame: Baseline
Measured by Wagner classification
Laboratory parameters and ulcer grade
Time frame: Baseline
Association between Hb, WBC, HbA1C, ESR, and CRP levels with Wagner ulcer grade
5 secondary outcomes
Duration of diabetes until ulcer onset
Time frame: Baseline
Smoking status and ulcer severity
Time frame: Baseline
Treatment outcomes
Time frame: At hospital discharge (average of 10 days)
Ulcer recurrence
Time frame: During 12-month follow-up (based on records)
Demographic distribution
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Yes
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
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 and Diabetes Complications, run by Golestan University of Medical sciences at 1 site in Iran.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. 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 Iran. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pezhman Kharazm (09111751861, pezhmankh@goums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of diabetic foot ulcer (measured by Wagner classification at admission) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.