Chronic Leg UlcersULCERENCT00709631
Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
An observational study of Chronic Leg Ulcers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leg Ulcers
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to May 2010
- 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 one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency.
Who may be able to join
- leg ulcer of more than 3 months of duration
- leg ulcer presumed of vascular origin
- adequate etiologic treatment since 3 months
- absence of evidence of healing : absence of reduction of wound area or increase in wound area and/or in depth
Who cannot join
- hypertensive ulcer
- vasculitis
- treatment by cytotoxic agents or steroids in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.
Read the detailed description
Prospective multicentric inclusion of 150 patients with leg ulcers without any evidence of healing (no change or increase of ulcer area) despite 3 months of adequate treatment The study population consisted of consecutive patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency. All patients undergo a standard treatment including compression therapy adapted to the ankle brachial index and a local treatment depending on the wound stage.At inclusion, systematic punch biopsies (5-6 mm) are taken as part of routine clinical care under local anaesthetic by an experienced clinician: 1 to 2 biopsies in the edges and 1 to 2 biopsies in the wound bedSpecimens are transported in formalin solution to the usual pathology laboratory of the investigator. At the end of the study, specimens will be sent for immunostainings in a single pathology laboratory (Rouen, France)Treatments and/or other investigations are decided by the investigatorAt 12 months of usual follow-up, final diagnosis and prognosis are noted in the study file by the investigator.
- Conditions
- Chronic Leg Ulcers
- Keywords
- Malignant transformation of leg ulcer, MARJOLIN's ulcer, Biopsy, Leg ulcer, Chronic wound, Squamous cell carcinoma, Basal cell carcinoma
- Medical subject headings
- Leg Ulcer, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionMay 2010
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 Chronic Leg UlcersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Patricia SENET, MD, Principal investigator, AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709631
- Sponsor's protocol ID
- 00006477
- Acronym
- ULCERE
- Status last verified
- Jun 2010
- First submitted
- 2 Jul 2008
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Senet P, Combemale P, Debure C, Baudot N, Machet L, Aout M, Vicaut E, Lok C; Angio-Dermatology Group Of The French Society Of Dermatology. Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study. Arch Dermatol. 2012 Jun;148(6):704-8. doi: 10.1001/archdermatol.2011.3362.
PubMed 22772403
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
- ClinicalTrials.gov ID
- NCT00709631
- Acronym / sponsor ID
- ULCERE / 00006477
- Conditions
- Chronic Leg Ulcers
- Keywords
- Malignant transformation of leg ulcer, MARJOLIN's ulcer, Biopsy, Leg ulcer, Chronic wound, Squamous cell carcinoma, Basal cell carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Jul 2008 (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.
Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.
Detailed description
Prospective multicentric inclusion of 150 patients with leg ulcers without any evidence of healing (no change or increase of ulcer area) despite 3 months of adequate treatment The study population consisted of consecutive patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency. All patients undergo a standard treatment including compression therapy adapted to the ankle brachial index and a local treatment depending on the wound stage.At inclusion, systematic punch biopsies (5-6 mm) are taken as part of routine clinical care under local anaesthetic by an experienced clinician: 1 to 2 biopsies in the edges and 1 to 2 biopsies in the wound bedSpecimens are transported in formalin solution to the usual pathology laboratory of the investigator. At the end of the study, specimens will be sent for immunostainings in a single pathology laboratory (Rouen, France)Treatments and/or other investigations are decided by the investigatorAt 12 months of usual follow-up, final diagnosis and prognosis are noted in the study file by the investigator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency.
Key inclusion criteria (4 listed)
- leg ulcer of more than 3 months of duration
- leg ulcer presumed of vascular origin
- adequate etiologic treatment since 3 months
- absence of evidence of healing : absence of reduction of wound area or increase in wound area and/or in depth
Key exclusion criteria (3 listed)
- hypertensive ulcer
- vasculitis
- treatment by cytotoxic agents or steroids in the previous 3 months
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
Not reported in the source record.
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 25 Feb 2015.
- Derived from this study: PubMed 22772403Senet P, Combemale P, Debure C, Baudot N, Machet L, Aout M, Vicaut E, Lok C; Angio-Dermatology Group Of The French Society Of Dermatology. Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study. Arch Dermatol. 2012 Jun;148(6):704-8. doi: 10.1001/archdermatol.2011.3362.
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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.
Patricia SENET, MD principal investigator
AP-HP, Hôpital Charles Foix, 94205 Ivry/Seine, France et Hôpital Tenon, 75020 Paris, France
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 Chronic Leg Ulcers, run by Assistance Publique - Hôpitaux de Paris 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 3 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 25 Feb 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709631, 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 25 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.