NCT02392390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

March 13, 2015

Last Update Submit

April 6, 2016

Conditions

Leg Ulcer

Keywords

Topical Dynamic PhototherapyMicrobiota

Outcome Measures

Primary Outcomes (3)

  • The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

    Baseline (Day 0)

  • The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample

    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

    Day 0: immediately after phototherapy

Secondary Outcomes (18)

  • The percentage of commensal bacteria among bacteria species isolated per sample

    Baseline (Day 0)

  • The percentage of commensal bacteria among bacteria species isolated per sample

    Day 0: immediately after Metvixia rinsing and right before phototherapy

  • The percentage of commensal bacteria among bacteria species isolated per sample

    Day 0: immediately after phototherapy

  • The number of bacteria taxa detected per sample

    Baseline (Day 0)

  • The number of bacteria taxa detected per sample

    Day 0: immediately after Metvixia rinsing and right before phototherapy

  • +13 more secondary outcomes

Other Outcomes (13)

  • Age in years

    Day 0 (baseline)

  • Gender

    Day 0 (baseline)

  • Body mass index

    Day 0 (baseline)

  • +10 more other outcomes

Study Arms (1)

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)

Procedure: Topical Dynamic Phototherapy (TDP)Drug: Metvixia cream

Interventions

Topical Dynamic Phototherapy (TDP)PROCEDURE

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.

The study population
Metvixia creamDRUG
The study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laurent Meunier, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

FR(1)