An observational study in Diabetic Foot Ulcer and Diabetes Complications, sponsored by Golestan University of Medical sciences. Recruiting at 1 site in Iran. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Golestan University of Medical sciences · Observational
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
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
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
Exclusion Criteria:
Severity of diabetic foot ulcer (measured by Wagner classification at admission)
Measured by Wagner classification
Time frame: Baseline
Laboratory parameters and ulcer grade
Association between Hb, WBC, HbA1C, ESR, and CRP levels with Wagner ulcer grade
Time frame: Baseline
Duration of diabetes until ulcer onset
Time (in years) between diabetes diagnosis and first DFU occurrence
Time frame: Baseline
Smoking status and ulcer severity
Correlation between smoking history (yes/no) and Wagner ulcer grade
Time frame: Baseline
Treatment outcomes
Frequency of outcomes: antibiotic therapy, wound debridement, or amputation
Time frame: At hospital discharge (average of 10 days)
Ulcer recurrence
Number of hospital readmissions due to DFU.
Time frame: During 12-month follow-up (based on records)
Demographic distribution
Age, sex, occupation, and ethnicity of DFU patients
Time frame: Baseline
Plan to share: Yes
Supporting information: Study protocol
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Golestan University of Medical sciences