DiabetesQVP-DiaNCT05165758
Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique
An observational study of Diabetes and Diabetes Mellitus, run by University Hospital Center of Martinique at 1 site in France.
Trial summary
The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Foot Ulcer, Diabetic
- What is being tested?
- Self-assessment questionnaires
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2022to 17 Jun 2022
- 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 subjects
Who may be able to join
- People of 18 years old and over,
- Diabetics living in Martinique,
- Patient having been informed of the research,
- Patient agreeing to participate in the study.
Who cannot join
- Minor patient,
- Hospitalized patients during inclusion phase,
- Patients with confusional syndrome,
- Patient presenting a cognitive state making it difficult to complete the questionnaire,
- Patient under legal protection, under guardianship or under curatorship,
- Patient who refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Center of Martinique
Fort-de-France, Martinique, 97261
About this study
The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.
Read the detailed description
Diabetes is one of the most frequent pathologies in Martinique (French West Indies) in terms of prevalence, as are its complications. The diabetic foot ulcer is a real public health problem considering its impact on the island.
It has already been shown that diabetic patients have a lower quality of life than the overall population. It is now time to compare the quality of life of diabetics with and without foot ulcer in Martinique.
Such a complication has a social impact that should not be overlooked in primary, secondary and tertiary prevention.
- Being tested
- Self-assessment questionnaires
- Keywords
- Diabete, Diabete complications, Diabetic foot ulcer, socio-economic disparities
- 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.
Self-assessment questionnairesOther
Subjects will pass the SF-36 score (mental health items) and the EPICES index
| Study group | Role | What they receive |
|---|---|---|
| Diabetic subjects without foot ulcer | 27 diabetic subjects without foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé) Receives: Other: Self-assessment questionnaires | |
| Diabetic subjects with foot ulcer | 54 diabetic subjects presenting foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé) Receives: Other: Self-assessment questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the levels of quality of life in diabetic subjects with and without foot ulcer
The primary endpoint will be the score on the mental health dimension of the SF-36 score
Measured: 6 months
Secondary outcomes (4)
Compare the levels of precarity in diabetic subjects with and without foot ulcer
To evaluate the level of precarity, the EPICES score will be calculated for both type of subjects.
Measured: 6 months
Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer
To evaluate the level of quality of life according to HbA1c, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.
Measured: 6 months
Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer
To evaluate the level of quality of life according to the duration of diabetes, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.
Measured: 6 months
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer
To evaluate the level of quality of life according to the antidiabetic treatment, the score of the mental health dimension of the SF-36 questionnaire will be calculated for both type of subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start21 Jan 2022
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel BOURGADE, MD, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165758
- Sponsor's protocol ID
- 21_RIPH3-04
- Acronym
- QVP-Dia
- Status last verified
- Sep 2022
- First submitted
- 8 Dec 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique
- ClinicalTrials.gov ID
- NCT05165758
- Acronym / sponsor ID
- QVP-Dia / 21_RIPH3-04
- Keywords
- Diabete, Diabete complications, Diabetic foot ulcer, socio-economic disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 21 Dec 2021 (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 aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.
Detailed description
Diabetes is one of the most frequent pathologies in Martinique (French West Indies) in terms of prevalence, as are its complications. The diabetic foot ulcer is a real public health problem considering its impact on the island.
It has already been shown that diabetic patients have a lower quality of life than the overall population. It is now time to compare the quality of life of diabetics with and without foot ulcer in Martinique.
Such a complication has a social impact that should not be overlooked in primary, secondary and tertiary prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic subjects without foot ulcer | – | Other: Self-assessment questionnaires27 diabetic subjects without foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé) |
| Diabetic subjects with foot ulcer | – | Other: Self-assessment questionnaires54 diabetic subjects presenting foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic subjects
Key inclusion criteria (4 listed)
- People of 18 years old and over,
- Diabetics living in Martinique,
- Patient having been informed of the research,
- Patient agreeing to participate in the study.
Key exclusion criteria (6 listed)
- Minor patient,
- Hospitalized patients during inclusion phase,
- Patients with confusional syndrome,
- Patient presenting a cognitive state making it difficult to complete the questionnaire,
- Patient under legal protection, under guardianship or under curatorship,
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 |
|---|---|---|
| Self-assessment questionnairesSubjects will pass the SF-36 score (mental health items) and the EPICES index | Other | Diabetic subjects with foot ulcer, Diabetic subjects without foot ulcer |
Primary outcome
Compare the levels of quality of life in diabetic subjects with and without foot ulcer
Time frame: 6 months
The primary endpoint will be the score on the mental health dimension of the SF-36 score
4 secondary outcomes
Compare the levels of precarity in diabetic subjects with and without foot ulcer
Time frame: 6 months
Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer
Time frame: 6 months
Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer
Time frame: 6 months
Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer
Time frame: 6 months
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 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Miguel BOURGADE, MD principal investigator
University Hospital Center of Martinique
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 and Diabetes Mellitus, run by University Hospital Center of Martinique 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 4 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 13 Sep 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 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?
Compare the levels of quality of life in diabetic subjects with and without foot ulcer (time frame: 6 months). 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 13 Sep 2022.