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Assessment Of Infrared Photobiotherapy for Improved Wound Healing

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ClinicalTrials.gov Identifier: NCT00426166
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment
Wound Healing Device: Low Level Laser Therapy

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2007
Primary Completion Date : March 2009
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Low Level Laser Therapy
Device: Low Level Laser Therapy
Low Level Laser Therapy on Wound
No Intervention: 2
No Laser Therapy. Outcome Measures the same.


Outcome Measures

Primary Outcome Measures :
  1. Acute Traumatic Injury (ATI) patients treated with LLLT will experience a [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]
  2. Decrease in post-operative pain as measured by the FACES Pain Rating Scale [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]
  3. Reduction in amount of pain medication needed to control pain [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]
  4. Improvement in wound healing as measured by serial photographs of wound appearance and rate of wound healing. [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]

Secondary Outcome Measures :
  1. Additional factors that may influence pain (type of injury, perioperative blood loss, smoking) [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]
  2. Improvement in Quality of Life as measured by the SF-36 [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426166


Locations
United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
Principal Investigator: Martin Skie, MD University of Toledo Health Science Campus
More Information

Responsible Party: Martin Skie, MD, University of Toledo, Health Science Campus
ClinicalTrials.gov Identifier: NCT00426166     History of Changes
Other Study ID Numbers: MUO-06
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: March 2010