29 Aug Neuropathy Relief Center of Miami Research Review: Randomized Controlled Trial Treatment of diabetic foot ulcers in a frail population with severe co-morbidities using at-home photobiomodulation laser therapy: a double-blind, randomized, sham-controlled pilot clinical study
Purpose: To evaluate the safety and efficacy of an at-home photobiomodulation (PBM) device for the treatment of diabetic foot ulcers (DFUs) in a frail population with severe comorbidities.
Methods: Prospective, randomized, double-blind, sham-controlled pilot study. Patients (age = 63 ± 11 years, male:female 13:7) with insulin-dependent diabetes type 2, neuropathy, peripheral
artery disease, significant co-morbidities, and large osteomyelitis-associated DFUs (University of Texas grade ≥ III) were randomized to receive active (n = 10) or sham (n = 10) at-home daily
PBM treatments (pulsed near-infrared 808 nm Ga-Al-As laser, 250 mW, 8.8 J/cm2) for up to 12 weeks in addition to standard care. The primary outcome was the %wound size reduction. The
secondary was adverse events.
Results: With the numbers available, PBM-treated group had significantly greater %reduction compared to sham (area [cm2], baseline vs endpoint: PBM 10[20.3] cm2 vs 0.2[2.4] cm2; sham, 7.9 [12.0] cm2 vs 4.6 [13.8] cm2, p = 0.018 by Mann-Whitney U test). Wound closure > 90% occurred in 7 of 10 PBM-treated patients but in only 1 of 10 sham patients (p = 0.006). No adverse device effects were observed.
Conclusions: Photobiomodulation at home, in addition to standard care, may be effective for the treatment of severe DFUs in frail patients with co-morbidities and is particularly relevant at these times of social distancing. Our preliminary results justify the conduction of a larger clinical trial.
If you have been diagnosed with peripheral neuropathy or have neuropathy symptoms such as pain, burning, numbness in your arms, hands, legs or feet. Please contact us at (305) 275-7475 to schedule and discuss your questions with our new patient specialist or message us your number/email and our team member will reach out to you for scheduling.
Out of town patients can schedule a complimentary Zoom Meeting Consultation or Phone Consultation with Dr. Alfonso. Please contact either by website, email, or by phone if you have any questions. We are here to help you overcome peripheral neuropathy and get you back to enjoying life! You can beat peripheral neuropathy without drugs or surgery!
Dr. Alfonso Neuropathy Treatment Protocol
● Improves and increases oxygen and nutrition through the increase of circulation to the damaged nerves.
● Repairs peripheral fibers by stimulating regeneration of new nerve cells.
● Removes and eliminates mechanical peripheral nerve entrapments and compressions in the spine and extremities
Dr. Alfonso‘s Neuropathy Treatment Protocol utilizes 8 specialized treatments designed to improve the supply of oxygen, eliminate waste, and improve nutrition to damaged nerves.
Increased circulation to the damaged peripheral nerves combined with treatments to stimulate peripheral nerve cell regeneration, and repair.
For more info on the Dr. Alfonso Neuropathy Treatment Protocol please visit our treatment page of our website.
I look forward to meeting and helping you!
Sincerely Yours for Health,
Dr. Rodolfo Alfonso, D.C.
8585 Sunset Drive,
Miami, FL 33143