Diabetic Foot UlcerNCT04300205
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
A study testing High intensity LED light device in people with Diabetic Foot Ulcer, run by Illumacell Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- High intensity LED light device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2020to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic and venous lower limb ulcers less than or equal to 5cm in diameter
- healable wounds
- non-cancerous wounds
Who cannot join
- pregnant or breast feeding women
- participants taking photosensitive drugs for concomitant disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Health Services - Lower Limb Wound Care
Lethbridge, Alberta
About this study
Official title: High Intensity LED Photobiomodulation (PBM) Therapy for Chronic Leg and Foot Ulcers
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- High intensity LED light device, Sham LED light device
- Keywords
- diabetic foot ulcer, venous foot ulcer, phototherapy, photobiomodulation, LED light
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity LED light deviceDevice
Participant wounds are treated with LED light device for 10 minutes, 4 times over the course of 2 months
Sham LED light deviceDevice
Participants have the light treatment moved off their wound after masking
| Study group | Role | What they receive |
|---|---|---|
| High intensity LED light treatment | Experimental | Participants treated with high intensity LED phototherapy Receives: 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 Receives: Device: Sham LED light device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start25 Feb 2020
- Primary completion30 Jul 2021
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumacell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kerber Applied Research, Alberta Health Services - Lower Limb Wound Clinic
- Responsible party
- Sponsor
- Investigators
- Jeff Hummel, PhD, Study director, Illumacell Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300205
- Sponsor's protocol ID
- WCAB-89340
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity LED Photobiomodulation (PBM) Therapy for Chronic Leg and Foot Ulcers
- ClinicalTrials.gov ID
- NCT04300205
- Acronym / sponsor ID
- WCAB-89340
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetic foot ulcer, venous foot ulcer, phototherapy, photobiomodulation, LED light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Illumacell Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kerber Applied Research, Alberta Health Services - Lower Limb Wound Clinic
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High intensity LED light treatment | Experimental | Device: High intensity LED light deviceParticipants treated with high intensity LED phototherapy |
| Sham high intensity LED light treatment | Experimental | Device: Sham LED light deviceParticipants set up to be treated with light device but after being masked, the device is moved off the wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diabetic and venous lower limb ulcers less than or equal to 5cm in diameter
- healable wounds
- non-cancerous wounds
Key exclusion criteria (2 listed)
- pregnant or breast feeding women
- participants taking photosensitive drugs for concomitant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity LED light deviceParticipant wounds are treated with LED light device for 10 minutes, 4 times over the course of 2 months | Device | High intensity LED light treatment |
| Sham LED light deviceParticipants have the light treatment moved off their wound after masking | Device | Sham high intensity LED light treatment |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Website contains Abstract and Data Summary for "ILLUMACELL AND AHS PROFESSIONAL SUMMARY OF WOUND CARE ALBERTA (WCAB) STUDY"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Hummel, PhD study director
Illumacell Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity LED light device in people with Diabetic Foot Ulcer, run by Illumacell Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound healing time (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.