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High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers

NCT04300205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-09-28

No results posted yet for this study

Summary

Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was $547 million. Standard clinical care for these types of wounds has improved but there is still a great need for new wound care treatments to help speed up wound healing and reduce pain. One such treatment is high intensity LED light therapy. There is a long history of light therapy showing faster wound healing, reduced pain and reduced swelling. The research we propose here is to study a new high intensity LED light made by Kerber Applied Research Inc., to see if it reduces pain and speeds up healing lower leg ulcers. This research is a partnership between Kerber Applied Research Inc and the Lethbridge Lower Limb Wound Clinic, an Alberta Health Services program in Lethbridge, Alberta.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

High intensity LED light device

Participant wounds are treated with LED light device for 10 minutes, 4 times over the course of 2 months

DEVICE

Sham LED light device

Participants have the light treatment moved off their wound after masking

Sponsors & Collaborators

  • Kerber Applied Research

    collaborator UNKNOWN

  • Alberta Health Services - Lower Limb Wound Clinic

    collaborator UNKNOWN

  • Illumacell Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Hummel, PhD · Illumacell Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2021-07-30
Completion
2022-06-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300205 on ClinicalTrials.gov