Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Assessment of Infrared Photobiotherapy for Improved Wound Healing
1 other identifier
interventional
27
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedApril 23, 2025
April 1, 2025
2.2 years
January 22, 2007
November 11, 2014
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
FACES Pain Rating Scale Scores
The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.
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.
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.
12 weeks after surgery
Secondary Outcomes (15)
36-Item Short Form Survey - Bodily Pain Scores
baseline (2 weeks after surgery)
36-Item Short Form Survey - Bodily Pain Scores
6 weeks after surgery
36-Item Short Form Survey - Bodily Pain Scale
12 weeks after surgery
36-Item Short Form Survey - General Health
2 weeks after surgery (baseline)
36-Item Short Form Survey - General Health
6 weeks after surgery
- +10 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALLow Level Laser Therapy
2
NO INTERVENTIONNo Laser Therapy. Outcome Measures the same.
Interventions
7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.
Eligibility Criteria
You may qualify if:
- Age \> 18 and \< 85 years
- Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
- Currently resides within 100 miles of UMC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Toledo, Health Science Campus
Toledo, Ohio, 43614, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Martin Skie
- Organization
- University of Toledo
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Skie, MD
University of Toledo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 22, 2007
First Posted
January 24, 2007
Study Start
January 1, 2007
Primary Completion
March 1, 2009
Study Completion
May 1, 2011
Last Updated
April 23, 2025
Results First Posted
September 19, 2024
Record last verified: 2025-04