Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04300205 |
| Other study ID # |
WCAB-89340 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 25, 2020 |
| Est. completion date |
June 25, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Illumacell Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
