Diabetes MellitusDIAFOOTNCT03782129
Five-year Mortality Rate in People With Diabetic Foot Ulcer
An observational study of Diabetes Mellitus and Diabetic Foot, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU). This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot, Diabetes Complications
- What is being tested?
- blood samples and Clinical exam and DFU medical cares
- How many people
- 347 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Dec 2018
- 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: Diabetic patients with a DFU diagnosed in 2010
Who may be able to join
- type 1 or 2 diabetes
- consultation for new diabetic foot ulcer during the year 2010
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, 75013
About this study
As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).
This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.
Read the detailed description
Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure.
Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.
But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010.
Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.
- Conditions
- Diabetes Mellitus, Diabetic Foot, Diabetes Complications
- Being tested
- blood samples, Clinical exam and DFU medical cares
- Keywords
- diabetes mellitus, diabetic foot, mortality rate, diabetes complications
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
Blood samples drawn during hospitalisations when needed
Clinical exam and DFU medical caresOther
Clinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with DFU | Diabetic patients with DFU diagnosed in 2010 Receives: Biological: blood samples; Other: Clinical exam and DFU medical cares |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate 5 years after DFU diagnosis
Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.
Measured: 5 years
Secondary outcomes (1)
Risks factors correlated to mortality rate among DFU patients diagnosed in 2010
All relevants staisticals associations between mortality rate and DFU diagnosed in 2010
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study startMar 2009
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782129
- Sponsor's protocol ID
- CIC1421-18-16
- Acronym
- DIAFOOT
- Status last verified
- Dec 2018
- First submitted
- 14 Dec 2018
- Last updated
- 20 Dec 2018
- 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 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Mortality Rate in People With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03782129
- Acronym / sponsor ID
- DIAFOOT / CIC1421-18-16
- Conditions
- Diabetes Mellitus, Diabetic Foot, Diabetes Complications
- Keywords
- diabetes mellitus, diabetic foot, mortality rate, diabetes complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Dec 2018 (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.
As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).
This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.
Detailed description
Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure.
Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.
But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010.
Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with DFU | – | Biological: blood samples, Other: Clinical exam and DFU medical caresDiabetic patients with DFU diagnosed in 2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with a DFU diagnosed in 2010
Key inclusion criteria (2 listed)
- type 1 or 2 diabetes
- consultation for new diabetic foot ulcer during the year 2010
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| blood samplesBlood samples drawn during hospitalisations when needed | Biological | Diabetic patients with DFU |
| Clinical exam and DFU medical caresClinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death. | Other | Diabetic patients with DFU |
Primary outcome
Mortality rate 5 years after DFU diagnosis
Time frame: 5 years
Five years after DFU diagnosis, patients are called by phone to enquire their health. If patients are dead, family tell us. If no family is available, the City Hall is called to check the death list.
1 secondary outcome
Risks factors correlated to mortality rate among DFU patients diagnosed in 2010
Time frame: 5 years
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 20 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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 Diabetes Mellitus and Diabetic Foot, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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 2 inclusion and 1 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 20 Dec 2018. 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 France. 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?
Mortality rate 5 years after DFU diagnosis (time frame: 5 years). 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 20 Dec 2018.