Resistant Vascular UlcersPhase 2MAUVNCT00820274
Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
A Phase 2 study testing amniotic membranes in people with Resistant Vascular Ulcers, run by University Hospital, Limoges at 3 sites in France.
Trial summary
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers. To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Vascular Ulcers
- What is being tested?
- amniotic membranes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2009to Jun 2016
- Phase
- Phase 2
- 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
Who may be able to join
- Obtained informed consent
- Leg or foot arterial or mixed ulcer older than at least 3 months
Who cannot join
- No obtained informed consent
- Possibility for surgical treatment (revascularisation)
- Age less than 18
- Pregnancy
- Indication for major amputation (below /above the knee)
- Venous ulcer
- Ulcer with infection and / or necrosis
- Mycotic ulcer
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Médecine Interne et Pathologie Vasculaire
Bordeaux, 33075
Service de Chirurgie Vasculaire et Viscérale
Bordeaux, 33076
Service de Chirurgie Thoracique, cardiovasculaire et angiologie
Limoges, 87000
About this study
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.
To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.
To evaluate rate of amputations and recurrence at one year after complete cicatrisation
Read the detailed description
Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.
Main criterias:
Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).
Secondary criterias:
Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.
Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.
- Conditions
- Resistant Vascular Ulcers
- Being tested
- amniotic membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic membranesProcedure or surgery
The amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way
| Study group | Role | What they receive |
|---|---|---|
| amniotic membranes | Experimental | Not described Receives: Procedure: amniotic membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the diameter of the ulcer
Measured: Every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionJun 2016 (estimated)
Why it stopped: clinical trial have encountered difficulties enrolling a sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant Vascular UlcersStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Francis Pesteil, MD, Principal investigator, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820274
- Sponsor's protocol ID
- I07011
- Acronym
- MAUV
- Status last verified
- Dec 2013
- First submitted
- 9 Jan 2009
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cryopreserved Amniotic Membranes in the Care of Resistant Vascular Ulcers
- ClinicalTrials.gov ID
- NCT00820274
- Acronym / sponsor ID
- MAUV / I07011
- Conditions
- Resistant Vascular Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: clinical trial have encountered difficulties enrolling a sufficient number of patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Jan 2009 (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.
To evaluate tolerance and efficiency of cryopreserved amniotic membranes in local treatment of resistant vascular ulcers.
To evaluate complete cicatrisation, efficiency on pain, prevention of infection, improvement of quality of life.
To evaluate rate of amputations and recurrence at one year after complete cicatrisation
Detailed description
Treatment of patients suffering from vascular ulcers or amputation's wound from at least 6 months after or without possibility for surgical treatment. A cryopreserved amniotic membrane, obtained after caesarean from consenting women without any disease, is applied on the ulcer after serological checking and changed once a week.
Main criterias:
Tolerance will be evaluated on clinical criterias. Efficiency will be evaluated by measuring reduction of ulcer's area (reduction of at least 50 % at 6 months).
Secondary criterias:
Reduction of pain will be evaluated by analogic visual scale and evaluation of analgesic consumption.
Evaluation of infections, amputations, complete healing, improvement of quality of life by SF36 questionnaire and recurrence at one year for patients with complete healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amniotic membranes | Experimental | Procedure: amniotic membranes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obtained informed consent
- Leg or foot arterial or mixed ulcer older than at least 3 months
Key exclusion criteria (8 listed)
- No obtained informed consent
- Possibility for surgical treatment (revascularisation)
- Age less than 18
- Pregnancy
- Indication for major amputation (below /above the knee)
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 |
|---|---|---|
| amniotic membranesThe amniotic membrane is taken with a sterile crowbar then applied side foetal face against the ulcer and displayed in a homogeneous way | Procedure or surgery | amniotic membranes |
Primary outcome
Measure of the diameter of the ulcer
Time frame: Every week
Results and safety
The study was stopped early (reason given: clinical trial have encountered difficulties enrolling a sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
Francis Pesteil, MD principal investigator
CHU Limoges
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amniotic membranes in people with Resistant Vascular Ulcers, run by University Hospital, Limoges at 3 sites 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 8 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: stopped early, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: clinical trial have encountered difficulties enrolling a sufficient number of patients). Results are not available in the source record.
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?
Measure of the diameter of the ulcer (time frame: Every week). 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 1 Sep 2015.