search
Back to results

Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Primary Purpose

Wound Healing

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Level Laser Therapy
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Toledo, Health Science Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Low Level Laser Therapy

No Laser Therapy. Outcome Measures the same.

Outcomes

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

Full Information

First Posted
January 22, 2007
Last Updated
May 9, 2011
Sponsor
University of Toledo Health Science Campus
search

1. Study Identification

Unique Protocol Identification Number
NCT00426166
Brief Title
Assessment Of Infrared Photobiotherapy for Improved Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Low Level Laser Therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
No Laser Therapy. Outcome Measures the same.
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
Low Level Laser Therapy on Wound
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Skie, MD
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo, Health Science Campus
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Assessment Of Infrared Photobiotherapy for Improved Wound Healing

We'll reach out to this number within 24 hrs