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Active, Not Recruiting

NCT Number: NCT06768554

Predictive Analysis 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Foot Ulcer (DFU) Cardiovascular Diseases Diabetes Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Disease Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Clinical Medical Research Center for Metabolic Diseases (Shanghai)

Shanghai, China

About this study

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:

  • 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.
  • 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.
  • By comparing the effects of different treatment methods (such as drug therapy, surgical intervention, adjuvant therapy, etc.), the most suitable treatment strategy is found.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Ulcer healing rate in diabetic foot ulcers

    Time frame: Look at the last 10 years retrospectively

  2. Ulcer recurrence rate in diabetic foot ulcer patients

    Time frame: Look at the last 10 years retrospectively

  3. Amputation rate in diabetic foot ulcers

    Time frame: Look at the last 10 years retrospectively

  4. Mortality of diabetic foot ulcers

    Time frame: Look at the last 10 years retrospectively

Secondary outcomes

  1. Key independent factors that affect wound healing

    Time frame: Look at the last 10 years retrospectively

    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).

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Retrospective Analysis of Prognostic Indicators of Diabetic Foot Ulcer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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