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

Lasers Med Sci. 2022 Mar;37(2):919-928. doi: 10.1007/s10103-021-03335-9. Epub 2021 May 29.


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.

Keywords: Diabetic foot ulcer; Frail elderly; Low-level laser therapy; Photobiomodulation; Wound healing.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Diabetes Mellitus*
  • Diabetic Foot* / radiotherapy
  • Double-Blind Method
  • Female
  • Frail Elderly
  • Humans
  • Lasers
  • Low-Level Light Therapy* / methods
  • Male
  • Middle Aged
  • Morbidity
  • Pilot Projects
  • Prospective Studies
  • Wound Healing

Associated data