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Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Sponsor
University of Toledo Health Science Campus (Other)
Overall Status
Completed
CT.gov ID
NCT00426166
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
51.9
Duration (Months)
1
Patients Per Site Per Month

Study Details

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 Phase
  • Device: Low Level Laser Therapy
 N/A

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
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
May 1, 2011

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 [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 [baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline]

  3. Reduction in amount of pain medication needed to control pain [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. [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) [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 [baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00426166
Other Study ID Numbers:
  • MUO-06
First Posted:
Jan 24, 2007
Last Update Posted:
May 10, 2011
Last Verified:
Mar 1, 2010
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of May 10, 2011