Diabetic Foot Ulcer (DFU)NCT06768554
Predictive Analysis of Diabetic Foot Ulcer
An observational study of Diabetic Foot Ulcer (DFU) and Diabetic Foot Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Diabetic Foot Disease, Diabetes
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic foot ulcer patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
National Clinical Medical Research Center for Metabolic Diseases (Shanghai)
Shanghai
About this study
Official title: 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.
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:
- 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.
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetic Foot Disease, Diabetes
- Being tested
- Level of blood sugar control (e.g., hemoglobin A1C), severity of infection, blood supply status, and other complications (e.g., peripheral neuropathy)
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer healing rate in diabetic foot ulcers
Measured: Look at the last 10 years retrospectively
Ulcer recurrence rate in diabetic foot ulcer patients
Measured: Look at the last 10 years retrospectively
Amputation rate in diabetic foot ulcers
Measured: Look at the last 10 years retrospectively
Mortality of diabetic foot ulcers
Measured: 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).
Measured: Look at the last 10 years retrospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start31 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768554
- Sponsor's protocol ID
- CCEMD-20241001
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Prognostic Indicators of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06768554
- Acronym / sponsor ID
- CCEMD-20241001
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetic Foot Disease, Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic foot ulcer patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level 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) | Other | – |
Primary outcome
Ulcer healing rate in diabetic foot ulcers
Time frame: Look at the last 10 years retrospectively
Ulcer recurrence rate in diabetic foot ulcer patients
Time frame: Look at the last 10 years retrospectively
Amputation rate in diabetic foot ulcers
Time frame: Look at the last 10 years retrospectively
Mortality of diabetic foot ulcers
Time frame: Look at the last 10 years retrospectively
1 secondary outcome
Key independent factors that affect wound healing
Time frame: Look at the last 10 years retrospectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer (DFU) and Diabetic Foot Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer healing rate in diabetic foot ulcers (time frame: Look at the last 10 years retrospectively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.