- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04300205
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
High Intensity LED Photobiomodulation (PBM) Therapy for Chronic Leg and Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: To test the safety of a new LED light therapy device on patients with chronic diabetic or venous lower extremity ulcers, and to determine whether the light device decreases pain and accelerates wound healing.
Hypothesis: Patients with chronic diabetic or venous foot/leg ulcers treated with standard care plus 10 minutes of high intensity LED light therapy will experience less overall pain associated with their ulcer and the ulcer will heal faster than standard care alone.
Justification: Diabetic and venous foot ulcers are debilitating, costly, extremely painful and interfere significantly with quality of life. Standard care for chronic wounds has improved but there is great need of new treatments to complement wound care, reduce pain, and accelerate wound healing. High intensity LED light therapy is a re-emerging treatment option that is known to decrease inflammation, decrease pain, and increase tissue regeneration.
Objectives: The primary objective is to assess the safety of a high intensity LED light device (KPTL-10) in the treatment of chronic foot and leg ulcers. The secondary objectives are to assess the ability of the KPTL-10 device to reduce pain and accelerate wound healing.
Research Method/Procedures: Participants with chronic foot and leg ulcers less than 8 cm in diameter (longest direction) will randomized into one of 2 groups for this study: 1) to receive a free 10 minute light treatment with the KPTL10 device in addition to standard care, or 2) strictly be a part of the standard care control group (no light treatment). For treatment, the light device is placed at a fixed distance (1 cm) above the wound. All participants will have wound measurements taken with digital software throughout the course of the study to track wound healing. Patients will also record their pain levels by filling out a VAS pain scale throughout the study.
Plan for Data Analysis: For each study participant, detailed Case Report Forms will be completed by study researchers and the principal investigator Dr. Eric Bly at every study appointment. The target numbers for this study data set are 40 treated participants, and 20 control (untreated) participants. These case report forms contain data sections to capture wound sizes, patient experiences post treatment, and pain scores (VAS scale). All data will be stored digitally on a single study computer and manually as printed hardcopies for study records and complete data analysis by Dr. Eric Bly and Illumacell's clinical team.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Lethbridge, Alberta, Canada
- Alberta Health Services - Lower Limb Wound Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diabetic and venous lower limb ulcers less than or equal to 5cm in diameter
- healable wounds
- non-cancerous wounds
Exclusion Criteria:
- pregnant or breast feeding women
- participants taking photosensitive drugs for concomitant disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity LED light treatment
Participants treated with high intensity LED phototherapy
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Participant wounds are treated with LED light device for 10 minutes, 4 times over the course of 2 months
|
Experimental: Sham high intensity LED light treatment
Participants set up to be treated with light device but after being masked, the device is moved off the wound
|
Participants have the light treatment moved off their wound after masking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wound healing time
Time Frame: 4 months
|
To determine whether high intensity LED therapy promotes changes in healing time of chronic foot ulcers.
Participants will have the area (cm2) of their wounds calculated using Imitomeasure digital imaging software.
Wound size will be tracked over the course of 4 light treatments.
|
4 months
|
Altered pain experience associated with chronic wounds
Time Frame: 4 months
|
To determine whether high intensity LED therapy leads to altered pain experienced during standard care of chronic foot ulcers.
Participants pain will be assessed by completing a pain questionnaire including the VAS pain scale measurement, over the course of 4 light treatments.
Participants will complete the VAS pain scale measurement before and after each treatment.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jeff Hummel, PhD, Illumacell Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCAB-89340
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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