Assessment Of Infrared Photobiotherapy for Improved Wound Healing - Full Text View

Sponsored by:	University of Toledo Health Science Campus
Information provided by:	University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:	NCT00426166

Purpose

The purpose of this study is to examine whether or not LLLT can reduce pain and/or improve wound healing in patients with an acute traumatic injury to the upper extremity (wrist, forearm, or elbow).

Condition	Intervention
Wound Healing	Device: Low Level Laser Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Acute Traumatic Injury (ATI) patients treated with LLLT will experience a
Decrease in post-operative pain as measured by the FACES Pain Rating Scale
Reduction in amount of pain medication needed to control pain
Improvement in wound healing as measured by serial photographs of wound appearance and rate of wound healing.

Secondary Outcome Measures:

Additional factors that may influence pain (type of injury, perioperative blood loss, smoking)
Improvement in Quality of Life as measured by the SF-36

Estimated Enrollment:	50
Study Start Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 and < 85 years
Acute traumatic injury of an upper extremity (wrist, forearm, or elbow)
Currently resides within 100 miles of UMC

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426166

Contacts

Contact: Martin Skie, MD

419-383-3761

mskie@meduohio.edu

Locations

United States, Ohio
Medical University of Ohio at Toledo	Recruiting
Toledo, Ohio, United States, 43614
Contact: Martin Skie, MD 419-383-3761 mskie@meduohio.edu

Sponsors and Collaborators

University of Toledo Health Science Campus

Investigators

Principal Investigator:

Martin Skie, MD

University of Toledo Health Science Campus

More Information

Study ID Numbers:	MUO-06
Study First Received:	January 22, 2007
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00426166
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 13, 2009