Predictive Analysis of Diabetic Foot Ulcer

NCT06768554 | Active Not Recruiting

• 1 other identifier: CCEMD-20241001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to retrospectively analyze the wound condition, limb condition, ulcer recurrence and cardiovascular and mortality of patients with diabetic foot ulcer after admission to our hospital from 2009 to 2014, so as to understand the changes in the condition of patients with diabetic foot ulcer after treatment, provide evidence for the treatment of diabetic foot, and clarify the risk of diagnosis and treatment of diabetic foot.

Conditions

Diabetic Foot Ulcer (DFU); Diabetic Foot Disease; Diabetes

Outcome Measures

Primary Outcomes (4)

• Ulcer healing rate in diabetic foot ulcers

  Look at the last 10 years retrospectively

• Ulcer recurrence rate in diabetic foot ulcer patients

  Look at the last 10 years retrospectively

• Amputation rate in diabetic foot ulcers

  Look at the last 10 years retrospectively

• Mortality of diabetic foot ulcers

  Look at the last 10 years retrospectively

Secondary Outcomes (1)

• Key independent factors that affect wound healing

  Look at the last 10 years retrospectively

Interventions

Level of blood sugar control (e.g., hemoglobin A1C), severity of infection, blood supply status, and other complications (e.g., peripheral neuropathy) OTHER

Level of blood sugar control (e.g., hemoglobin A1C), severity of infection, blood supply status, and other complications (e.g., peripheral neuropathy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic foot ulcer patients

You may qualify if:

• Age ≥ 18 years old
• Gender: males and females
• Patients diagnosed with diabetic foot ulcers (including those on the Wagner scale 0-5)
• Receive inpatient treatment during the designated study period

You may not qualify if:

• Patients with severe systemic disease (such as end-stage renal disease, advanced cancer, etc.) may have influenced the study results
• Patients unable to complete follow-up or with incomplete data

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

National Clinical Medical Research Center for Metabolic Diseases (Shanghai)

Shanghai, China

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

Hemoglobin A

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 10, 2025
• Study Start: October 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-10

Locations

CN (1)