Predictive Analysis of Diabetic Foot Ulcer

Retrospective Analysis of Prognostic Indicators of Diabetic Foot Ulcer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes; Diabetic Foot Ulcer (DFU); Diabetic Foot Disease
• Intervention / Treatment: Other: Level of blood sugar control (e.g., hemoglobin A1C), severity of infection, blood supply status, and other complications (e.g., peripheral neuropathy)

Detailed Description

Diabetic foot ulcer (DFU) is one of the most common and serious complications in patients with diabetes. Due to its high incidence and complicated treatment process, DFU often has a significant impact on patients' quality of life. In order to gain an in-depth understanding of the wound changes of diabetic foot patients after admission, this study aims to systematically analyze the data of the database of diabetic foot patients in Ruijin Hospital, analyze the wound healing, ulcer recurrence and limb changes of diabetic foot patients, including amputation and other conditions, and then further determine the main factors affecting diabetic foot ulcer healing. Guide clinicians to develop more effective treatment plans; Provide data support to help optimize the treatment flow of diabetic foot and reduce length of stay and recurrence rates; To improve the overall treatment effect of diabetic foot patients and improve their quality of life.

Objective:

1. The wound condition, limb condition, ulcer recurrence and cardiovascular and mortality changes of patients with diabetic foot after treatment were analyzed to clarify the risk of diagnosis and treatment of the disease and provide evidence for the treatment of diabetic foot.
2. To assess the progress of wound healing in patients with diabetic foot after admission to hospital and identify key factors that promote or delay healing.
3. By comparing the effects of different treatment methods (such as drug therapy, surgical intervention, adjuvant therapy, etc.), the most suitable treatment strategy is found.
4. The incidence of complications during and after treatment was analyzed, and effective management strategies were discussed.

Methods:Through systematic analysis of the data from the database of diabetic foot patients in Ruijin Hospital, the wound healing, ulcer recurrence and limb changes of diabetic foot patients, including amputation, were analyzed, and then the main factors affecting diabetic foot ulcer healing were further determined.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • National Clinical Medical Research Center for Metabolic Diseases (Shanghai)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diabetic foot ulcer patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key independent factors that affect wound healing	Through in-depth analysis of the diabetic foot ulcer patient database, the study is expected to identify key independent factors that affect wound healing, including the patient's level of blood sugar control (such as hemoglobin A1C), severity of infection, blood supply status, and other complications (such as peripheral neuropathy and vascular disease).	Look at the last 10 years retrospectively

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Ulcer; Diabetic Foot; Foot Ulcer; Foot Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Chrysarobin
• Other Study ID Numbers: CCEMD-20241001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No