Diabetic FootNCT05186519
Amputation Associated Factors and Prediction Model in Diabetic Foot Patients
An observational study of Diabetic Foot, run by Qianfoshan Hospital at 1 site in China.
Trial summary
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. The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 15 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic foot who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2015 and October 15, 2021.
Who may be able to join
- Clinical diagnosis of diabetic foot
- Hospitalized patients
- No history of amputation
Who cannot join
- Patients with Bone Neoplasms
- Patients with osteomyelitis not caused by diabetes
- Patients with amputation caused by severe peripheral vascular disease not caused by diabetes
- Traumatic Amputations
- Patients in shock on admission
- Patients discharged against medical advice
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: Amputation Associated Factors and Prediction Model in Diabetic Foot Patients : A Retrospective Cohort Study
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.
The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective cohort and to construct a prediction model for patients at high amputated risk.
Read the detailed description
Diabetic foot is one of the major complications observed in patients with diabetes. Diabetic foot can lead to non-traumatic lower-limb amputation (LLA), and is confirmed to be associated with cognitive decline and worsening quality of life. Previous studies indicated that diabetics had a 25% lifetime risk of developing diabetic foot, and 14% to 24% of those require amputation. In patients with poor results of conservative treatment, amputation is the main terminal treatment option to avoid the spread of infection.
Amputation in diabetic foot patients may linked to different causes, including inflammatory, infectious and malignant conditions. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to evaluate the progression and prognosis of diabetic foot patients. A prediction model will be developed to identify high-risk diabetic foot patients of amputation and provide a scientific basis for personalized clinical care.
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot, Amputation, Cohort Study, Predict model
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
All non-traumatic amputate events
The main outcome was any non-traumatic amputation events among patients with diabetic foots including removing all of a limb or extremity (major amputation) or a portion of a limb or extremity (minor amputation).
Measured: through study completion, an average of 2.2 year
Secondary outcomes (3)
Composite outcomes of serious adverse
Including amputations, deaths and other adverse outcomes
Measured: through study completion, an average of 2.2 year
All-cause mortality
All-cause mortality during hospitalization in patients with diabetic foot.
Measured: through study completion, an average of 2.2 year
Length of stay in hospital
Hospital length of stay for diabetic foot treatment.
Measured: through study completion, an average of 2.2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2015
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- 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
- NCT05186519
- Sponsor's protocol ID
- CT2021-10-22
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amputation Associated Factors and Prediction Model in Diabetic Foot Patients : A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05186519
- Acronym / sponsor ID
- CT2021-10-22
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot, Amputation, Cohort Study, Predict model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Jan 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.
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.
The aim of this study is to assess factors associated with the occurrence of amputation events in the diabetic foot patients based on a retrospective cohort and to construct a prediction model for patients at high amputated risk.
Detailed description
Diabetic foot is one of the major complications observed in patients with diabetes. Diabetic foot can lead to non-traumatic lower-limb amputation (LLA), and is confirmed to be associated with cognitive decline and worsening quality of life. Previous studies indicated that diabetics had a 25% lifetime risk of developing diabetic foot, and 14% to 24% of those require amputation. In patients with poor results of conservative treatment, amputation is the main terminal treatment option to avoid the spread of infection.
Amputation in diabetic foot patients may linked to different causes, including inflammatory, infectious and malignant conditions. A retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform is conducted to evaluate the progression and prognosis of diabetic foot patients. A prediction model will be developed to identify high-risk diabetic foot patients of amputation and provide a scientific basis for personalized clinical care.
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
- Patients with diabetic foot who were hospitalized in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2015 and October 15, 2021.
Key inclusion criteria (3 listed)
- Clinical diagnosis of diabetic foot
- Hospitalized patients
- No history of amputation
Key exclusion criteria (6 listed)
- Patients with Bone Neoplasms
- Patients with osteomyelitis not caused by diabetes
- Patients with amputation caused by severe peripheral vascular disease not caused by diabetes
- Traumatic Amputations
- Patients in shock on admission
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
All non-traumatic amputate events
Time frame: through study completion, an average of 2.2 year
The main outcome was any non-traumatic amputation events among patients with diabetic foots including removing all of a limb or extremity (major amputation) or a portion of a limb or extremity (minor amputation).
3 secondary outcomes
Composite outcomes of serious adverse
Time frame: through study completion, an average of 2.2 year
All-cause mortality
Time frame: through study completion, an average of 2.2 year
Length of stay in hospital
Time frame: through study completion, an average of 2.2 year
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 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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 Qianfoshan Hospital 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 6 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 11 Jan 2022. 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?
All non-traumatic amputate events (time frame: through study completion, an average of 2.2 year). 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 11 Jan 2022.