N

Type of Study

Journal/Study Title

Investigators

49

Prospective study measuring sensation change in patients with diabetic peripheral neuropathy using quantitative monofilament testing before and after 12 30-minute treatments

Journal of the American Podiatric Medical Association, Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes, Vol. 92, No. 3, March 2002

Alan Kochman, MS, PT

Dale Carnegie, DPM

284

Prospective pain study measuring improvement in chronic myofascial pain after up to 12 Anodyne treatments; 92% had failed treatment with other therapies/modalities

Journal of Orthopedic Medicine and Surgery, Effects of Skin-Contact Monochromatic Infrared Irradiation on Tendonitis, Capsulitis, and Myofascial Pain, Volume 16, 1996

Tom Thomasson, DDS Oral surgeon and pain/ TMJ specialist

40

Randomized, placebo-controlled NCV study measuring improvement in negative peak latency over a 45-minute treatment

Journal of Clinical Laser Medicine and Surgery, Monochromatic Infrared Irradiation (890): Effect of a Multisource Array upon Conduction in the Human Median Nerve, Vol. 19, No. 6, 2001

Noble, Lowe, Baxter

University of Ulster at Jordanstown, Northern Ireland

N/A

Prospective wound study began as IRB-approved, double-blind, placebo-controlled study on venous and diabetic ulcers – 5 cases presented

Advances in Wound Care – Augmentation of Wound Healing Using Monochromatic Infrared Energy, January/February 1999

Lon Horwitz, DPM

Dale Carnegie, DPM

N

Type of Study

Symposia

Presenter

38

Retrospective, IRB-approved study using Anodyne combined with gait/ balance training in a physical therapy center to improve sensation, Tinetti gait/balance scores and fall rates

American Physical Therapy Association Combined Sections Meeting, Tampa, FL

February 2003

Alan Kochman, MS, PT

27

Prospective study with pre-treatment control used Neurometer CPT to measure changes in nerve function after ten 40-minute treatments

American Podiatric Medical Association, Washington, DC - August 2003

J. Joseph Prendergast, MD

27

Prospective IRB-approved, double-blind placebo-controlled measuring restoration of sensation using monofilament testing, neuropathic pain and self-reported balance after six to twelve 45 minute treatments

7^th Annual Wound Care Congress, San Antonio, TX - October 2003

American Association of Diabetes Educators, Salt Lake City, UT

August 2003

David Leonard, MD, FACE

Sara Myers, LPN, CCRC

2

Gangrene Reversal Case

Ischemic Wounds

Case of Resistant Dermatophytosis

17^th Annual Clinical Symposium on Skin and Wound Care, Dallas, TX

September 2002

Caroline Fife, MD

Mary Ann Lillig, DO,

Jennifer Stevens, RPT

N

Type of Study

Outcomes Measure

Investigator

27

Prospective IRB-approved, randomized, double-blind placebo-controlled

Restoration of sensation using monofilament testing, neuropathic pain and self-reported balance

Endocrinologists in major diabetes center

27

Prospective with pre-treatment control

Restoration of sensation using Neurometer CPT – an objective measure of nerve damage.

Endocrinologist

38

Retrospective IRB-approved study using Anodyne combined with gait and balance training in a physical therapy center to reduce falls

• Chart review of sensation improve-ments using monofilament testing
• Tinetti Gait and Balance Scores
• Falls in a 90-day period pre and post Anodyne treatment

Masters Prepared Physical Therapist

68

Retrospective Outcomes Survey of patients treated with Anodyne for minimum of one year at home

# of wounds, # of wounds that took more than 8 weeks to heal, pain, balance and activity levels in one year period pre and post home use of Anodyne

Orthopedic Surgeon, Podiatrist

N

Type of Study

Outcomes Measure

Investigator

15

IRB-approved study of in-home use of Anodyne over a 90-day period to determine quantitative improvements in neural function and local microcirculation

• Sensation improvement as measured by monofilament
• Objective measures of neural response
• Circulation improvement
• Quality of life indicators

Endocrinologists in major diabetes center

28

Restrospective, multi-site chart review of patients receiving Anodyne Therapy for multiple etiologies of neuropathy

• Sensation improvement using PSSD Quantitative Sensory Testing Device

Foot and Ankle Surgeons

N

Type of Study

Outcomes Measure

Investigator

10

IRB-approved, randomized, double-blind, placebo-controlled study using Anodyne daily on NLD Lesions

Size of lesions – active vs. placebo (warmth)

Endocrinologist in major diabetes center

30

IRB-approved, double-blind, placebo-controlled study using Anodyne

Sensation improvement using monofilament testing, pain, balance

Endocrinologist

60

IRB-approved, controlled study comparing Anodyne Therapy + Gait and Balance Training vs. Gait and Balance Training alone (current standard of care)

• Sensation improvement using monofilament testing
• Balance improvement using EquiTest, Tinitti, Timed Get up and Go

Masters-prepared physical therapist specializing in balance

200

IRB-approved multi-center chart review of treatment results in patients with DPN

• Sensation improvement using monofilament testing
• Functional outcomes – balance/gait

Masters Prepared Physical Therapist