The First In-Human Application of Continuous Low-Irradiance Phototherapy for Chronic Wounds: A Pilot Study

Area of Science:

• Biomedical Engineering
• Photomedicine
• Wound Healing Research

Background:

• Polymicrobial colonization and biofilm formation impede chronic wound healing, increasing complication risks.
• Continuous Low-Irradiance Phototherapy (CLIP) utilizes 405 nm blue light, avoiding thermal damage and promoting healing factors.
• Preclinical data suggest 405 nm light inhibits bacterial growth and biofilm formation.

Purpose of the Study:

• To conduct the first in-human evaluation of a device delivering continuous low-irradiance 405 nm light for chronic wound treatment.
• To assess the safety, feasibility, and ergonomics of the CLIP device in adult human subjects.
• To collect preliminary data on wound healing outcomes, including percentage area reduction.

Main Methods:

• A prospective observational pilot study involving 25 participants over 4 weeks.
• Participants received 24/7 continuous low-irradiance 405 nm light therapy.
• Primary endpoints included safety, usability by healthcare professionals, and patient comfort; secondary endpoint was percentage area reduction (PAR).

Main Results:

• No adverse events or patient discomfort were reported during the CLIP intervention.
• Healthcare staff reported no ergonomic or compliance issues, rating the device highly for practicality and ease of use.
• An average percentage area reduction (PAR) of 29% was observed in study participants.

Conclusions:

• This study represents the initial human trial of extended low-irradiance 405 nm light for chronic wound therapy.
• The CLIP device demonstrated a favorable safety profile, ease of use, and good compliance in an outpatient setting.
• Continuous CLIP treatment led to partial or complete wound area reduction in study participants.