CClinicalTrials.gg
Active, not recruitingNCT06768554Updated Jan 10, 2025

Predictive Analysis of Diabetic Foot Ulcer

An observational study in Diabetic Foot Ulcer (DFU), Diabetic Foot Disease and Diabetes, sponsored by Shanghai Jiao Tong University School of Medicine. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcer (DFU)
  • Diabetic Foot Disease
  • Diabetes
03

In context

Foot Diseases

55 studies on the registry are indexed under Foot Diseases; 11 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 120 across 13 observational studies indexed under Foot Diseases.

Browse Foot Diseases studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Diabetic foot ulcer patients

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Interventions

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

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

06

What researchers measure

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

    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).

    Time frame: Look at the last 10 years retrospectively

07

Study locations

1 site
  • National Clinical Medical Research Center for Metabolic Diseases (Shanghai)
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06768554
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Wang Weiqing (Professor, Ruijin Hospital) — Principal investigator
First posted
Jan 10, 2025
Start date
Oct 31, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Jan 10, 2025

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion