Wound HealingNCT00426166
Assessment Of Infrared Photobiotherapy for Improved Wound Healing
A study testing Low Level Laser Therapy in people with Wound Healing, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 85 years
- Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
- Currently resides within 100 miles of UMC
Who cannot join
- Pregnant
- Pacemaker
- Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
- Two or more cardiac risk factors
- Intraoperative complications
- Wound infection
- Open Wound
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
Official title: Assessment of Infrared Photobiotherapy for Improved Wound Healing
The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).
Read the detailed description
This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.
All subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.
- Conditions
- Wound Healing
- Being tested
- Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low Level Laser Therapy Receives: Device: Low Level Laser Therapy |
| 2 | No intervention | No Laser Therapy. Outcome Measures the same. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACES Pain Rating Scale Scores
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Measured: baseline (2 weeks after surgery)
FACES Pain Rating Scale Scores
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Measured: 6 weeks after surgery
FACES Pain Rating Scale.
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
Measured: 12 weeks after surgery
Secondary outcomes (15)
36-Item Short Form Survey - Bodily Pain Scores
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: baseline (2 weeks after surgery)
36-Item Short Form Survey - Bodily Pain Scores
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 weeks after surgery
36-Item Short Form Survey - Bodily Pain Scale
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks after surgery
36-Item Short Form Survey - General Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 2 weeks after surgery (baseline)
36-Item Short Form Survey - General Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 weeks after surgery
36-Item Short Form Survey - General Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks after surgery
36-Item Short Form Survey - Physical Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Physical Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 weeks after surgery
36-Item Short Form Survey - Physical Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks after surgery
36-Item Short Form Survey - Mental Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Mental Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 weeks after surgery
36-Item Short Form Survey - Mental Health
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks after surgery
36-Item Short Form Survey - Social Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Social Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 6 weeks after surgery
36-Item Short Form Survey - Social Function
Response to questions generates a numerical score, with a higher score representing a better outcome.
Measures health-related quality of life across 8 domains, with each domain scored on a scale of 0-100 with higher scores representing a better outcome. Items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealingStudies 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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Skie, MD, University of Toledo Health Science Campus
- Investigators
- Martin Skie, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426166
- Sponsor's protocol ID
- Wound Healing
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2007
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Infrared Photobiotherapy for Improved Wound Healing
- ClinicalTrials.gov ID
- NCT00426166
- Acronym / sponsor ID
- Wound Healing
- Conditions
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether or not Low Level Laser Therapy (LLLT) can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).
Detailed description
This is a prospective, two group, controlled study using random assignment. All eligible patients will be randomly assigned to one of two groups: the control group (usual care) or the experimental group (usual care plus LLLT). We plan to enroll 50 subjects in this study: 25 subjects will be randomly assigned to the LLLT group and 25 to the usual care group.
All subjects will be recruited within one to two days prior to hospital discharge or at the time of their first postoperative clinic visit. No subjects will be recruited while sedated or receiving intravenous pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Low Level Laser TherapyLow Level Laser Therapy |
| 2 | No intervention | –No Laser Therapy. Outcome Measures the same. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 and < 85 years
- Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
- Currently resides within 100 miles of UMC
Key exclusion criteria (7 listed)
- Pregnant
- Pacemaker
- Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
- Two or more cardiac risk factors
- Intraoperative complications
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 |
|---|---|---|
| Low Level Laser Therapy7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal. | Device | 1 |
Primary outcome
FACES Pain Rating Scale Scores
Time frame: baseline (2 weeks after surgery)
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
FACES Pain Rating Scale Scores
Time frame: 6 weeks after surgery
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
FACES Pain Rating Scale.
Time frame: 12 weeks after surgery
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
15 secondary outcomes
36-Item Short Form Survey - Bodily Pain Scores
Time frame: baseline (2 weeks after surgery)
36-Item Short Form Survey - Bodily Pain Scores
Time frame: 6 weeks after surgery
36-Item Short Form Survey - Bodily Pain Scale
Time frame: 12 weeks after surgery
36-Item Short Form Survey - General Health
Time frame: 2 weeks after surgery (baseline)
36-Item Short Form Survey - General Health
Time frame: 6 weeks after surgery
36-Item Short Form Survey - General Health
Time frame: 12 weeks after surgery
36-Item Short Form Survey - Physical Function
Time frame: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Physical Function
Time frame: 6 weeks after surgery
36-Item Short Form Survey - Physical Function
Time frame: 12 weeks after surgery
36-Item Short Form Survey - Mental Health
Time frame: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Mental Health
Time frame: 6 weeks after surgery
36-Item Short Form Survey - Mental Health
Time frame: 12 weeks after surgery
36-Item Short Form Survey - Social Function
Time frame: 2 weeks after surgery (baseline)
36-Item Short Form Survey - Social Function
Time frame: 6 weeks after surgery
36-Item Short Form Survey - Social Function
Time frame: 12 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martin Skie, MD principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Wound Healing, run by University of Toledo Health Science Campus at 1 site in United States.
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 7 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 23 Apr 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
FACES Pain Rating Scale Scores (time frame: baseline (2 weeks after surgery)). The study lists 3 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 23 Apr 2025.