Assessment Of Infrared Photobiotherapy for Improved Wound Healing

Wound Healing Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426166
• Other study ID #: MUO-06
• Status: Completed
• Phase: N/A
• First received: January 22, 2007
• Last updated: May 9, 2011
• Start date: January 2007
• Est. completion date: May 2011

Study information

• Verified date: March 2010
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing

Intervention

Device:
• Low Level Laser Therapy
Low Level Laser Therapy on Wound

Locations

Country	Name	City	State
United States	University of Toledo, Health Science Campus	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Traumatic Injury (ATI) patients treated with LLLT will experience a		baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Primary	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
Primary	Reduction in amount of pain medication needed to control pain		baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline
Primary	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	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
Secondary	Improvement in Quality of Life as measured by the SF-36		baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline