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RecruitingNCT07188337Updated Sep 23, 2025

Characteristics of Diabetic Foot Ulcer Patients

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

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study 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 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

02

Conditions studied

  • Diabetic Foot Ulcer
  • Diabetes Complications

Keywords

  • diabetic foot ulcer
  • diabetes mellitus
  • amputation
  • neuropathy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Incomplete or missing medical records
  • Patients with foot ulcers of non-diabetic etiology
  • Patients whose key laboratory data are unavailable
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Severity of diabetic foot ulcer (measured by Wagner classification at admission)

    Measured by Wagner classification

    Time frame: Baseline

  2. Laboratory parameters and ulcer grade

    Association between Hb, WBC, HbA1C, ESR, and CRP levels with Wagner ulcer grade

    Time frame: Baseline

Secondary outcomes

  1. Duration of diabetes until ulcer onset

    Time (in years) between diabetes diagnosis and first DFU occurrence

    Time frame: Baseline

  2. Smoking status and ulcer severity

    Correlation between smoking history (yes/no) and Wagner ulcer grade

    Time frame: Baseline

  3. Treatment outcomes

    Frequency of outcomes: antibiotic therapy, wound debridement, or amputation

    Time frame: At hospital discharge (average of 10 days)

  4. Ulcer recurrence

    Number of hospital readmissions due to DFU.

    Time frame: During 12-month follow-up (based on records)

  5. Demographic distribution

    Age, sex, occupation, and ethnicity of DFU patients

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • 5Th Azar Medical Center
    Gorgan, Outside of the US 4917956808, Iran
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07188337
Lead sponsor
Golestan University of Medical sciences
Responsible party
Pezhman Kharazm, MD (Assistant Professor of Vascular Surgery, Golestan University of Medical Sciences, Golestan University of Medical sciences) — Principal investigator
First posted
Sep 23, 2025
Start date
Jul 27, 2025
Primary completion
Oct 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Sep 23, 2025

Study contacts

Pezhman Kharazm
Contact
pezhmankh@goums.ac.ir
09111751861

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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