Trial Outcomes & Findings for Assessment Of Infrared Photobiotherapy for Improved Wound Healing (NCT NCT00426166)

Results Overview

The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

baseline (2 weeks after surgery)

Results posted on

2025-04-23

Participant Flow

Per the initial IRB application, the criteria for selection and exclusion was based on the following: Inclusion - Adult patients with unhealed wounds of the upper extremity. For Outcome Measures, study results were destroyed/shredded based on 3 year minimum record retention after completion of research. Not able to provide patient reported ranges. Only data available is means.

Participant milestones

Participant milestones
Measure	Low Level Laser Therapy Group Low Level Laser Therapy: 7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.	Standard Treatment Control Group No Laser Therapy. Outcome Measures the same.
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Level Laser Therapy Group n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Unknown gender	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (2 weeks after surgery)

The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
FACES Pain Rating Scale Scores	2.0 units on a scale All data related to the study has been destroyed. Only data available is means.	3.3 units on a scale All data related to the study has been destroyed. Only data available is means.

PRIMARY outcome

Timeframe: 6 weeks after surgery

The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
FACES Pain Rating Scale Scores	1.0 Units on a scale All data related to the study has been destroyed. Only data available is means.	2.5 Units on a scale All data related to the study has been destroyed. Only data available is means.

PRIMARY outcome

Timeframe: 12 weeks after surgery

The FACES pain scale ranged from 0-10, with lower scores representing less pain and better outcome.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
FACES Pain Rating Scale.	1.0 units on a scale Please note: Study results/data destroyed and not available to report outcome measures due to 3 year minimum record retention.	1.5 units on a scale Please note: Study results/data destroyed and not available to report outcome measures due to 3 year minimum record retention.

SECONDARY outcome

Timeframe: baseline (2 weeks after surgery)

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Bodily Pain Scores	45 Units in a scale All data related to the study has been destroyed. Only data available is means.	13 Units in a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Bodily Pain Scores	49 Units on a scale All data related to the study has been destroyed. Only data available is means.	44 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 12 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Bodily Pain Scale	45 Units on a scale All data related to the study has been destroyed. Only data available is means.	52 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 2 weeks after surgery (baseline)

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - General Health	70 Units on a scale All data related to the study has been destroyed. Only data available is means.	54 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - General Health	75 Units on a scale All data related to the study has been destroyed. Only data available is means.	58 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 12 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - General Health	60 Units on a scale All data related to the study has been destroyed. Only data available is means.	55 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 2 weeks after surgery (baseline)

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Physical Function	54 Units on a scale All data related to the study has been destroyed. Only data available is means.	52 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Physical Function	50 Units on a scale All data related to the study has been destroyed. Only data available is means.	70 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 12 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Physical Function	50 Units on a scale All data related to the study has been destroyed. Only data available is means.	63 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 2 weeks after surgery (baseline)

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Mental Health	59 Units on a scale All data related to the study has been destroyed. Only data available is means.	58 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Mental Health	58 Units on a scale All data related to the study has been destroyed. Only data available is means.	71 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 12 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Mental Health	60 Units on a scale All data related to the study has been destroyed. Only data available is means.	60 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 2 weeks after surgery (baseline)

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Social Function	55 Units on a scale All data related to the study has been destroyed. Only data available is means.	40 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 6 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Social Function	58 Units on a scale All data related to the study has been destroyed. Only data available is means.	84 Units on a scale All data related to the study has been destroyed. Only data available is means.

SECONDARY outcome

Timeframe: 12 weeks after surgery

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.

Outcome measures

Outcome measures
Measure	Low Level Laser Therapy n=13 Participants Low Level Laser Therapy: Low Level Laser Therapy on Wound	Standard Treatment Control Group n=14 Participants No Laser Therapy. Outcome Measures the same.
36-Item Short Form Survey - Social Function	58 Units on a scale All data related to the study has been destroyed. Only data available is means.	74 Units on a scale All data related to the study has been destroyed. Only data available is means.

Adverse Events

Low Level Laser Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martin Skie

University of Toledo

Phone: 419-383-3515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place