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

January 22, 2007
May 9, 2011
January 2007
March 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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.
Complete list of historical versions of study NCT00426166 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Additional factors that may influence pain (type of injury, perioperative blood loss, smoking)
  • Improvement in Quality of Life as measured by the SF-36
Not Provided
Not Provided
 
Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Not Provided

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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Wound Healing
Device: Low Level Laser Therapy
Low Level Laser Therapy on Wound
  • Experimental: 1
    Low Level Laser Therapy
    Intervention: Device: Low Level Laser Therapy
  • No Intervention: 2
    No Laser Therapy. Outcome Measures the same.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2011
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00426166
MUO-06
Not Provided
Martin Skie, MD, University of Toledo, Health Science Campus
University of Toledo Health Science Campus
Not Provided
Principal Investigator: Martin Skie, MD University of Toledo Health Science Campus
University of Toledo Health Science Campus
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP