Varicose UlcerBIOPULCERNCT02889913
When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care?
An observational study of Varicose Ulcer and Leg Ulcer, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Ulcer, Leg Ulcer
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jul 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris
Who may be able to join
- The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? Retrospective Study of 100 Consecutive Biopsies
Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Extrapolating these prevalences in the French population between 28 000 and 395 000 people are affected in France a leg ulcer.
It is a costly disease. In 2001, a French study conducted among 800 physicians, including 85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was estimated that the total cost of treatment per patient average was 888 32 euros. This is truly a public health problem.
Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed). However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis. These ulcers rare causes require specific treatments that can often heal. To diagnose, to perform a skin biopsy. Thus, the general practitioner must know when to put the indication for biopsy of a leg ulcer.
Read the detailed description
Goal :
Analyzing the last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, followed in the vascular medicine department of the Hospital Saint Joseph Paris, to determine:
- The reasons which motivated the doctor make the indication of biopsy:
- Disease duration of ulcer
- Unusual clinical features
- Other signs associated with ulcer
- Absence of a satisfactory explanation vascular
- The pathological results Purpose: To clear a typical profile ulcers biopsy
Methodology :
- Retrospective, single-center,
- Acquisition of data: via the pathology laboratory of the hospital will be collected the last 100 consecutive biopsies performed with leg ulcers in vascular medicine department of the hospital Saint Joseph Paris, between 1 January 2013 and the October 1, 2013. Then be analyzed all paper and electronic records of these patients.
- Grid and Analysis:
- Patient histories,
- vascular profile of patients,
- clinical and chronological criteria of the ulcer,
- Other signs associated with ulcer
- Results of histological biopsies.
- The data will be made anonymous on the grid for collection by a numbering system 1 100.
- Conditions
- Varicose Ulcer, Leg Ulcer
- Being tested
- No intervention only description
- Medical subject headings
- Varicose Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention only descriptionOther
No intervention only description
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of disease duration of ulcer
by calculating the number of days from ulceration to the healing
Measured: Day 1 of ulceration to the day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889913
- Sponsor's protocol ID
- Biopsie cutanée
- Acronym
- BIOPULCER
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? Retrospective Study of 100 Consecutive Biopsies
- ClinicalTrials.gov ID
- NCT02889913
- Acronym / sponsor ID
- BIOPULCER / Biopsie cutanée
- Conditions
- Varicose Ulcer, Leg Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Extrapolating these prevalences in the French population between 28 000 and 395 000 people are affected in France a leg ulcer.
It is a costly disease. In 2001, a French study conducted among 800 physicians, including 85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was estimated that the total cost of treatment per patient average was 888 32 euros. This is truly a public health problem.
Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed). However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis. These ulcers rare causes require specific treatments that can often heal. To diagnose, to perform a skin biopsy. Thus, the general practitioner must know when to put the indication for biopsy of a leg ulcer.
Detailed description
Goal :
Analyzing the last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, followed in the vascular medicine department of the Hospital Saint Joseph Paris, to determine:
- The reasons which motivated the doctor make the indication of biopsy:
- Disease duration of ulcer
- Unusual clinical features
- Other signs associated with ulcer
- Absence of a satisfactory explanation vascular
- The pathological results Purpose: To clear a typical profile ulcers biopsy
Methodology :
- Retrospective, single-center,
- Acquisition of data: via the pathology laboratory of the hospital will be collected the last 100 consecutive biopsies performed with leg ulcers in vascular medicine department of the hospital Saint Joseph Paris, between 1 January 2013 and the October 1, 2013. Then be analyzed all paper and electronic records of these patients.
- Grid and Analysis:
- Patient histories,
- vascular profile of patients,
- clinical and chronological criteria of the ulcer,
- Other signs associated with ulcer
- Results of histological biopsies.
- The data will be made anonymous on the grid for collection by a numbering system 1 100.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris
Key inclusion criteria (1 listed)
- The last 100 consecutive skin biopsies performed in patients carriers of chronic leg ulcers, hospitalized in the vascular medicine department of the Hospital Saint Joseph Paris
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| No intervention only descriptionNo intervention only description | Other | – |
Primary outcome
Assessment of disease duration of ulcer
Time frame: Day 1 of ulceration to the day 30
by calculating the number of days from ulceration to the healing
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 7 Sep 2016.
Related trials for Varicose Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
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 Varicose Ulcer and Leg Ulcer, run by Fondation Hôpital Saint-Joseph 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 1 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 7 Sep 2016. 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?
Assessment of disease duration of ulcer (time frame: Day 1 of ulceration to the day 30). 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 7 Sep 2016.