NCT07188337

Brief 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

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 31, 2025

Last Update Submit

September 20, 2025

Conditions

Keywords

diabetic foot ulcerdiabetes mellitusamputationneuropathy

Outcome Measures

Primary Outcomes (2)

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

    Measured by Wagner classification

    Baseline

  • Laboratory parameters and ulcer grade

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

    Baseline

Secondary Outcomes (5)

  • Duration of diabetes until ulcer onset

    Baseline

  • Smoking status and ulcer severity

    Baseline

  • Treatment outcomes

    At hospital discharge (average of 10 days)

  • Ulcer recurrence

    During 12-month follow-up (based on records)

  • Demographic distribution

    Baseline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

5Th Azar Medical Center

Gorgan, Outside of the US, 4917956808, Iran

RECRUITING

MeSH Terms

Conditions

Diabetic FootDiabetes ComplicationsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Pezhman Kharazm

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Vascular Surgery, Golestan University of Medical Sciences

Study Record Dates

First Submitted

August 31, 2025

First Posted

September 23, 2025

Study Start

July 27, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations