Diabetic FootNCT05519163
A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients.
An observational study of Diabetic Foot, run by Yibing Wang at 1 site in China.
Trial summary
A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 6,301 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021.
Who may be able to join
- Clinical diagnosis of type 2 diabetes
- Hospitalized patients
- The interval between two records is more than one year
Who cannot join
- Any history of ulcer or amputation previously
- The patients with type 1 diabetes
- Pregnant during the study
- Patients with malignant tumors
- Complicated with serious organ dysfunction, such as heart, liver and kidney
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
About this study
Official title: A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients: A Retrospective Cohort Study.
A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.
Read the detailed description
Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality.
Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.
- Conditions
- Diabetic Foot
- Keywords
- Diabetes Mellitus, Type 2, Diabetic Foot, Predictive model, cohort study
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New-onset diabetic foot
Diabetic foot was defined based on the self-reported disease history and clinical diagnosis from the electronic medical records. New-onset diabetic foot was diagnosed as the first-episode during the study period.
Measured: through study completion, an average of 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- 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
- 6,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yibing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yibing Wang, Qianfoshan Hospital
- Investigators
- Wang Yibing, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519163
- Sponsor's protocol ID
- YXLL-KY-2022(063)
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li MZ, Tang F, Liu YF, Lao JH, Yang Y, Cao J, Song R, Wu P, Wang YB. Risk factors and a predictive model of diabetic foot in hospitalized patients with type 2 diabetes. World J Diabetes. 2025 Mar 15;16(3):95644. doi: 10.4239/wjd.v16.i3.95644.
PubMed 40093275
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients: A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05519163
- Acronym / sponsor ID
- YXLL-KY-2022(063)
- Conditions
- Diabetic Foot
- Keywords
- Diabetes Mellitus, Type 2, Diabetic Foot, Predictive model, cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,301 participants (actual)
- Lead sponsor
- Yibing WangUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Aug 2022 (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.
A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.
Detailed description
Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality.
Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | – | –Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2021.
Key inclusion criteria (3 listed)
- Clinical diagnosis of type 2 diabetes
- Hospitalized patients
- The interval between two records is more than one year
Key exclusion criteria (5 listed)
- Any history of ulcer or amputation previously
- The patients with type 1 diabetes
- Pregnant during the study
- Patients with malignant tumors
- Complicated with serious organ dysfunction, such as heart, liver and kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
New-onset diabetic foot
Time frame: through study completion, an average of 32 months
Diabetic foot was defined based on the self-reported disease history and clinical diagnosis from the electronic medical records. New-onset diabetic foot was diagnosed as the first-episode during the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 40093275Li MZ, Tang F, Liu YF, Lao JH, Yang Y, Cao J, Song R, Wu P, Wang YB. Risk factors and a predictive model of diabetic foot in hospitalized patients with type 2 diabetes. World J Diabetes. 2025 Mar 15;16(3):95644. doi: 10.4239/wjd.v16.i3.95644.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
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.
Wang Yibing, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
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, run by Yibing Wang 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
New-onset diabetic foot (time frame: through study completion, an average of 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519163, which also lists 1 linked publication.
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 26 Apr 2024.