Abstract
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. ClinicalTrials.gov: NCT01493895.
Original language | English |
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Pages (from-to) | 919-928 |
Number of pages | 10 |
Journal | Lasers in Medical Science |
Volume | 37 |
Issue number | 2 |
DOIs | |
State | Published - Mar 2022 |
Keywords
- Aged
- Diabetes Mellitus
- Diabetic Foot/radiotherapy
- Diabetic foot ulcer
- Double-Blind Method
- Female
- Frail Elderly
- Frail elderly
- Humans
- Lasers
- Low-Level Light Therapy/methods
- Low-level laser therapy
- Male
- Middle Aged
- Morbidity
- Photobiomodulation
- Pilot Projects
- Prospective Studies
- Wound Healing
- Wound healing
All Science Journal Classification (ASJC) codes
- Dermatology
- Surgery