Ischemic Wound of the Lower LimbPhase 2FlammacériumNCT02385903
Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment
A Phase 2 study testing Flammacerium and Standard dressing procedure in people with Ischemic Wound of the Lower Limb and Necrotic Arterial Wounds, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Wound of the Lower Limb, Necrotic Arterial Wounds
- What is being tested?
- Flammacerium and Standard dressing procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Oct 2015
- 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
- Ischemic wound of the lower limb
- Minimum 50% necrosis
- Arteriopathy with ABI<0.7 or >1.3 with radiographic examinations
- No revascularisation procedure possible for any reasons
- No urgent amputation need
- Amputation considered in a short term
- Non life-threatened patients
Who cannot join
- Sulphonamide hypersensibility
- Propyleneglycols hypersensibility
- Enzyme glucose deshydrogenase deficiencies
- Others studies participation
- Tutorship or curatoship
Trial locations and contacts
1 site in 1 country.
About this study
Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.
- Being tested
- Flammacerium, Standard dressing procedure
- Keywords
- Flammacerium, Ischemic wound, Lower limb, Arteriopathy, Amputation, Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlammaceriumOther
Standard dressing procedureOther
| Study group | Role | What they receive |
|---|---|---|
| Standard dressing procedure | Other | One arm receive standard dressing procedure according to the wound Receives: Other: Standard dressing procedure |
| Flammacerium | Active comparator | Necrosis covering with Flammacerium 3 mm thick each day during one week then one day on two.
On each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears.
Cover Flammacerium by compress. Receives: Other: Flammacerium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation rate
Level of amputation
Measured: 6 months
Secondary outcomes (3)
Infection rate
Measured: 6 months
Wound size
Measured: 6 months
Pain during dressing (VAS)
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 posted11 Mar 2015 (estimated)
- Study startSep 2009
- Primary completionApr 2015
- Study completionOct 2015
Why it stopped: Decision of the Independent Review Committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Wound of the Lower LimbStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Rangueil Hospital, University Hospital, Caen, Beziers Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385903
- Sponsor's protocol ID
- 8546
- Acronym
- Flammacérium
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 2015
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Use of Flammacerium in Necrotic Arterial Wounds of the Lower Limb Versus Standard Treatment
- ClinicalTrials.gov ID
- NCT02385903
- Acronym / sponsor ID
- Flammacérium / 8546
- Keywords
- Flammacerium, Ischemic wound, Lower limb, Arteriopathy, Amputation, Dressing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of the Independent Review Committee
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Rangueil Hospital, University Hospital, Caen, Beziers Hospital
- Study start
- Sep 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Mar 2015 (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.
Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dressing procedure | Other | Other: Standard dressing procedureOne arm receive standard dressing procedure according to the wound |
| Flammacerium | Active comparator | Other: FlammaceriumNecrosis covering with Flammacerium 3 mm thick each day during one week then one day on two. On each dressing, remove excess and add flammacerium. Not to remove crust forming until eliminating furrow appears. Cover Flammacerium by compress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ischemic wound of the lower limb
- Minimum 50% necrosis
- Arteriopathy with ABI<0.7 or >1.3 with radiographic examinations
- No revascularisation procedure possible for any reasons
- No urgent amputation need
Key exclusion criteria (5 listed)
- Sulphonamide hypersensibility
- Propyleneglycols hypersensibility
- Enzyme glucose deshydrogenase deficiencies
- Others studies participation
- Tutorship or curatoship
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 |
|---|---|---|
| Flammacerium | Other | Flammacerium |
| Standard dressing procedure | Other | Standard dressing procedure |
Primary outcome
Amputation rate
Time frame: 6 months
Level of amputation
3 secondary outcomes
Infection rate
Time frame: 6 months
Wound size
Time frame: 6 months
Pain during dressing (VAS)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Decision of the Independent Review Committee). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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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?
A Phase 2 study testing Flammacerium and Standard dressing procedure in people with Ischemic Wound of the Lower Limb and Necrotic Arterial Wounds, run by University Hospital, Montpellier 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 7 inclusion and 5 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 Dec 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.
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: Decision of the Independent Review Committee). 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?
Amputation rate (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 1 Dec 2016.