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Assessment Of Infrared Photobiotherapy for Improved Wound Healing

This study has been completed.
Sponsor:
Information provided by:
University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT00426166
First received: January 22, 2007
Last updated: May 9, 2011
Last verified: March 2010
History of Changes
  Purpose

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 Intervention
Wound Healing
 Device: Low Level Laser Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

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 [ Time Frame: baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

No publications provided

Responsible Party: Martin Skie, MD, University of Toledo, Health Science Campus
ClinicalTrials.gov Identifier: NCT00426166     History of Changes
Other Study ID Numbers: MUO-06
Study First Received: January 22, 2007
Last Updated: May 9, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 13, 2013