Assessment Of Infrared Photobiotherapy for Improved Wound Healing

NCT ID: NCT00426166

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Low Level Laser Therapy

Group Type: EXPERIMENTAL

Low Level Laser Therapy

Intervention Type: DEVICE

7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.

2

No Laser Therapy. Outcome Measures the same.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low Level Laser Therapy

7500 megawatts with a 980 nm treatment beam every 48 hours for two weeks beginning at suture removal.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toledo Health Science Campus

OTHER

Sponsor Role: lead

Responsible Party

Martin Skie, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Skie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

University of Toledo, Health Science Campus

Toledo, Ohio, United States

Countries

United States

Other Identifiers

Wound Healing

Identifier Type: -

Identifier Source: org_study_id