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
; 37(2): 919-928, 2022 Mar.
Article
em En
| MEDLINE
| ID: mdl-34052927
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, malefemale 137) 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pé Diabético
/
Terapia com Luz de Baixa Intensidade
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Diabetes Mellitus
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Aged
/
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Lasers Med Sci
Assunto da revista:
BIOTECNOLOGIA
/
RADIOLOGIA
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Israel