Leg UlcerPDT-BactérioNCT02392390
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
A study testing Topical Dynamic Phototherapy (TDP) and Metvixia cream in people with Leg Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- Topical Dynamic Phototherapy (TDP) and Metvixia cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- 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
- Patient correctly informed concerning study implementation, objectives, constraints and patient rights
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient presents with one or more leg ulcers (artieral, venous or mixed)
- Afebrile patient without periulcerous erythema and who does not require antibiotic therapy
- Patient who has not received antibiotic treatment during the last 7 Days
- Nota bene: Patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. If the patient has multiple ulcers atn the same stage, the deepest wound will be considered.
Who cannot join
- The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contraindication for a treatment used in this study
- Patient with an infected leg ulcer treated with antibiotics
- Patients on curative anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.
Read the detailed description
The secondary objectives of this study are:
- To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session).
- Describe the evolution of the size and appearance of the wound 7d after the start of treatment
- Describe the potential adverse events associated with a TDP session
- Conditions
- Leg Ulcer
- Being tested
- Topical Dynamic Phototherapy (TDP), Metvixia cream
- Keywords
- Topical Dynamic Phototherapy, Microbiota
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Dynamic Phototherapy (TDP)Procedure or surgery
Metvixia cream is applied to the lesion (about 1mm thickness) and the treated zone is covered with an opaque dression for 3 hours. Any residual cream is removed an and the lesion immediately rinsed with saline solution when uncovering. One session (8 minutes) of phototherapy is then performed using an Altilite lamp in accordance with HAS (haute authorité de santé) recommendations.
Metvixia creamDrug
| Study group | Role | What they receive |
|---|---|---|
| The study population | Experimental | A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment.
Intervention: Topical Dynamic Phototherapy (TDP) Receives: Procedure: Topical Dynamic Phototherapy (TDP); Drug: Metvixia cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Measured: Baseline (Day 0)
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Measured: Day 0: immediately after phototherapy
Secondary outcomes (18)
The percentage of commensal bacteria among bacteria species isolated per sample
Measured: Baseline (Day 0)
The percentage of commensal bacteria among bacteria species isolated per sample
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The percentage of commensal bacteria among bacteria species isolated per sample
Measured: Day 0: immediately after phototherapy
The number of bacteria taxa detected per sample
Measured: Baseline (Day 0)
The number of bacteria taxa detected per sample
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The number of bacteria taxa detected per sample
Measured: Day 0: immediately after phototherapy
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
Measured: Baseline (Day 0)
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Shannon's H with log2
Measured: Day 0: immediately after phototherapy
The number of functional groups detected per sample
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Measured: Baseline (Day 0)
The number of functional groups detected per sample
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The number of functional groups detected per sample
Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.
Measured: Day 0: immediately after phototherapy
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
Measured: Baseline (Day 0)
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
Measured: Day 0: immediately after Metvixia rinsing and right before phototherapy
The diversity of functional groups detected per sample (Shannon's H with log2)
Shannon's H with log 2
Measured: Day 0: immediately after phototherapy
Adverse events
Measured: Day 0
Adverse events
Measured: Day 7
Visual analog scale for pain during the phototherapy session
Scale from 0 to 10
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Meunier, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392390
- Sponsor's protocol ID
- LOCAL/2014/LM-01
- Other IDs
- 2014-004668-40, 2014
- Acronym
- PDT-Bactério
- Status last verified
- Apr 2016
- First submitted
- 13 Mar 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
- ClinicalTrials.gov ID
- NCT02392390
- Acronym / sponsor ID
- PDT-Bactério / LOCAL/2014/LM-01
- Conditions
- Leg Ulcer
- Keywords
- Topical Dynamic Phototherapy, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 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.
The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.
Detailed description
The secondary objectives of this study are:
- To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session).
- Describe the evolution of the size and appearance of the wound 7d after the start of treatment
- Describe the potential adverse events associated with a TDP session
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | Experimental | Procedure: Topical Dynamic Phototherapy (TDP), Drug: Metvixia creamA total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment. Intervention: Topical Dynamic Phototherapy (TDP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient correctly informed concerning study implementation, objectives, constraints and patient rights
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient presents with one or more leg ulcers (artieral, venous or mixed)
- Afebrile patient without periulcerous erythema and who does not require antibiotic therapy
Key exclusion criteria (8 listed)
- The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
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 |
|---|---|---|
| Topical Dynamic Phototherapy (TDP)Metvixia cream is applied to the lesion (about 1mm thickness) and the treated zone is covered with an opaque dression for 3 hours. Any residual cream is removed an and the lesion immediately rinsed with saline solution when uncovering. One session (8 minutes) of phototherapy is then performed using an Altilite lamp in accordance with HAS (haute authorité de santé) recommendations. | Procedure or surgery | The study population |
| Metvixia cream | Drug | The study population |
Primary outcome
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time frame: Baseline (Day 0)
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
Time frame: Day 0: immediately after phototherapy
18 secondary outcomes
The percentage of commensal bacteria among bacteria species isolated per sample
Time frame: Baseline (Day 0)
The percentage of commensal bacteria among bacteria species isolated per sample
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The percentage of commensal bacteria among bacteria species isolated per sample
Time frame: Day 0: immediately after phototherapy
The number of bacteria taxa detected per sample
Time frame: Baseline (Day 0)
The number of bacteria taxa detected per sample
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The number of bacteria taxa detected per sample
Time frame: Day 0: immediately after phototherapy
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Time frame: Baseline (Day 0)
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The diversity of bacteria taxa detected per sample (Shannon's H with log2)
Time frame: Day 0: immediately after phototherapy
The number of functional groups detected per sample
Time frame: Baseline (Day 0)
The number of functional groups detected per sample
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The number of functional groups detected per sample
Time frame: Day 0: immediately after phototherapy
The diversity of functional groups detected per sample (Shannon's H with log2)
Time frame: Baseline (Day 0)
The diversity of functional groups detected per sample (Shannon's H with log2)
Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy
The diversity of functional groups detected per sample (Shannon's H with log2)
Time frame: Day 0: immediately after phototherapy
Adverse events
Time frame: Day 0
Adverse events
Time frame: Day 7
Visual analog scale for pain during the phototherapy session
Time frame: Day 0
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 Apr 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.
Laurent Meunier, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Dynamic Phototherapy (TDP) and Metvixia cream in people with Leg Ulcer, run by Centre Hospitalier Universitaire de Nīmes 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 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: finished, as of the sponsor's last update on 7 Apr 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?
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample (time frame: Baseline (Day 0)). The study lists 3 primary outcomes in all. 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 Apr 2016.