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Completed

NCT Number: NCT02392390

Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

METVIXIA Cream

Drug

Primary outcomes

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

    Time frame: Baseline (Day 0)

  2. 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

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

    Time frame: Day 0: immediately after phototherapy

Secondary outcomes

  1. The percentage of commensal bacteria among bacteria species isolated per sample

    Time frame: Baseline (Day 0)

  2. The percentage of commensal bacteria among bacteria species isolated per sample

    Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

  3. The percentage of commensal bacteria among bacteria species isolated per sample

    Time frame: Day 0: immediately after phototherapy

  4. The number of bacteria taxa detected per sample

    Time frame: Baseline (Day 0)

  5. The number of bacteria taxa detected per sample

    Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

  6. The number of bacteria taxa detected per sample

    Time frame: Day 0: immediately after phototherapy

  7. The diversity of bacteria taxa detected per sample (Shannon's H with log2)

    Time frame: Baseline (Day 0)

    Shannon's H with log2

  8. 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

    Shannon's H with log2

  9. The diversity of bacteria taxa detected per sample (Shannon's H with log2)

    Time frame: Day 0: immediately after phototherapy

    Shannon's H with log2

  10. The number of functional groups detected per sample

    Time frame: Baseline (Day 0)

    Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.

  11. The number of functional groups detected per sample

    Time frame: Day 0: immediately after Metvixia rinsing and right before phototherapy

    Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.

  12. The number of functional groups detected per sample

    Time frame: Day 0: immediately after phototherapy

    Function groups are predefined according to the presence/absence of each of the following factors: pathogen, anaerobic, cocci.

  13. The diversity of functional groups detected per sample (Shannon's H with log2)

    Time frame: Baseline (Day 0)

    Shannon's H with log 2

  14. 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

    Shannon's H with log 2

  15. The diversity of functional groups detected per sample (Shannon's H with log2)

    Time frame: Day 0: immediately after phototherapy

    Shannon's H with log 2

  16. Adverse events

    Time frame: Day 0

  17. Adverse events

    Time frame: Day 7

  18. Visual analog scale for pain during the phototherapy session

    Time frame: Day 0

    Scale from 0 to 10

Other outcomes

  1. Age in years

    Time frame: Day 0 (baseline)

  2. Gender

    Time frame: Day 0 (baseline)

  3. Body mass index

    Time frame: Day 0 (baseline)

  4. Number of lesions

    Time frame: Day 0 (baseline)

  5. Initial wound care or follow up?

    Time frame: Day 0 (baseline)

  6. If follow up visit, is the wound aggravated, stable or improving?

    Time frame: Day 0 (baseline)

  7. If follow up visit, is the wound aggravated, stable or improving?

    Time frame: Day 7

  8. Age of the target lesion in days

    Time frame: Day 0 (baseline)

  9. Location of the target lesion

    Time frame: Day 0 (baseline)

    Heel, internal malleolus or external malleolus

  10. Wound appearance

    Time frame: Day 0 (baseline)

    burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  11. Presence/absence of signs of infection

    Time frame: Day 0 to Day 7

    Purulent discharge, local inflammatory signs, rough bony contact, associated osteitis without bone contact, bacteremia, severe sepsis

  12. Change in the size of the wound (mm^2)

    Time frame: Day 7 versus baseline

  13. Irradiation dose (minutes)

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study

Acronym: PDT-Bactério

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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