High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers

NCT04300205 | Completed

• 1 other identifier: WCAB-89340
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetic foot ulcer; venous foot ulcer; phototherapy; photobiomodulation; LED light

Outcome Measures

Primary Outcomes (2)

• Change in wound healing time

  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

  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

Study Arms (2)

High intensity LED light treatment

EXPERIMENTAL

Participants treated with high intensity LED phototherapy

Device: High intensity LED light device

Sham high intensity LED light treatment

EXPERIMENTAL

Participants set up to be treated with light device but after being masked, the device is moved off the wound

Device: Sham LED light device

Interventions

High intensity LED light device DEVICE

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

High intensity LED light treatment

Sham LED light device DEVICE

Participants have the light treatment moved off their wound after masking

Sham high intensity LED light treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetic and venous lower limb ulcers less than or equal to 5cm in diameter
• healable wounds
• non-cancerous wounds

You may not qualify if:

• pregnant or breast feeding women
• participants taking photosensitive drugs for concomitant disease

Sponsors & Collaborators

• Illumacell Inc.: lead
• Kerber Applied Research: collaborator
• Alberta Health Services - Lower Limb Wound Clinic: collaborator

Study Sites (1)

Alberta Health Services - Lower Limb Wound Care

Lethbridge, Alberta, Canada

Location

Related Links

• Website contains Abstract and Data Summary for "ILLUMACELL AND AHS PROFESSIONAL SUMMARY OF WOUND CARE ALBERTA (WCAB) STUDY"

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Jeff Hummel, PhD

  Illumacell Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants wear black-out glasses during LED phototherapy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 9, 2020
• Study Start: February 25, 2020
• Primary Completion: July 30, 2021
• Study Completion: June 25, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CA (1)