Clinical Trials Studying LED Light Therapy

Effects of Light Therapy on Wound Healing (2012 – 2014)

Clement J. Zablocki VA Medical Center, Milwaukee, WI is researching the effect of NIR light on wounds.  Our Veterans suffering from pressure sores will be the target group.  Measurement of wounds will be the data collected.  First patient has been enrolled.

Study on the efficacy of NIR light in patients presenting with diabetic retinopathy (2011 - 2013)

This trial is being conducted at Cleveland’s VA Hospital.  PI is Dr. Johnny Tang. Currently has 6 patients enrolled. Enrollment is limited to Veterans. Funding provided by Veteran’s Administration.

A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type (2009 - 2011) identifier: NCT00940407-  other study ID #s: TORPA 08001 

Dr. Robert Dotson, Oak Ridge, TN and Dr. Graham Merry, Toronto, Canada conducted this study in their ophthalmology clinics and provided their own funding.
Objectives of this study were: 

This protocol is a multi center (US & Canada) 18 patient study utilizing 2 devices to give combination red and infrared treatment.

The study is completed and showed favorable results.  The data is in the process of being shared.

A Multi-institutional Trial To Evaluate The Prophylactic Use Of NASA-Developed Light Emitting Diodes For The Prevention Of Oral Mucositis In Bone Marrow Transplant Patients (2000 - 2009) identifier: NCT00036712-  other study ID #s: CDR0000069293, MCW-HRRC-28600, MCW-CHW-0070, NCI-V02-1699

Children’s Hospital , Milwaukee, WI enrolled 20 patients to research efficacy in the treatment of Oral Mucositis in Chemotherapy/Radiation Oncology patients.  This was a NASA-funded Phase II study.  The results of this study showed promise.

This spurred additional NASA funding for a Phase III randomized, double-blind, multicenter study.  University of Alabama – Birmingham and their affiliate Children’s Hospital along with Children’s Hospital Milwaukee enrolled 80 patients. Objectives were: 

The Phase III protocol was changed from the Phase II study; rather than measure mucositis wounds and pain, the Phase III solely focused on reduction of pain.  And rather than begin at day 1 of Chemo-radiation therapy it was started 7-10 days later, at Day 1 of Bone Marrow transplant.  With the changes to this Phase III trial, the results were not quite as measurable as the Phase II study. Thus additional patient trials are needed.

Gallium Nitrate for the Treatment of Malignant Tumors, A Phase I Study (1999 - 2008) identifier:  NCT00002543 -  other study ID #s: CDR0000063244, MCW-ARRC-22393, CHW-93/59, NCI-T93-0097D

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore Boston Floating Hospital Infants and Children, Boston and Medical College of Wisconsin with funding from NCI enrolled 3 patients at each dose level to reach the following objectives:

This study had some favorable results but again a better mortality rate and the opportunity to treat much sooner during disease course would bring better results. 

Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study (1994 - 1999) identifier: NCT00002647 – other study ID #s: CDR0000064165, MCW-7594, MCW-CHW-511, MCW-CHW-9411, NCI-V95-0652

Medical College of Wisconsin Cancer Center and Midwest Children’s Cancer Center at Children’s Hospital of Wisconsin with funding from National Cancer Institute enrolled patients. Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. Objectives of this study were: 

Results showed a need for more research and a larger patient population that had a better chance for survival most patients enrolled had a minimum 2 month life expectancy with all other treatment options exhausted.  

This website is intended for healthcare professionals and clinical researchers only. All of the treatments using LED phototherapy devices that are discussed on this website are in various stages of investigation and have not been approved by the FDA except where specifically stated.

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