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
Haze A, Haze A, Gavish L, Elishoov O, Shorka D, Tsohar T, Gellman YN, Liebergall M
Lasers in medical science · 27 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2021-05-29 · Lasers Med Sci · vol. 37 · número 2 · págs. 919–928
- Editorial
- Springer Science+Business Media
- Citado
- 34 citas · más que el 90% de estudios similares · 2.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 51 trabajos
- Acceso
- De pago
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Diabetic Foot Ulcer Assessment and Management · Wound Healing and Treatments
- Palabras clave
- diabetic foot ulcer, low-level laser therapy, home treatment, vulnerable patients, comorbidities, osteomyelitis, wound healing, wound size reduction, peripheral arterial disease, diabetic neuropathy, type 2 diabetes, near-infrared laser, social distancing
- MeSH
- humans, diabetic foot, diabetes mellitus, morbidity, prospective studies, pilot projects, double-blind method, lasers, wound healing, aged, frail elderly, middle aged, female, male, low-level light therapy
7 autores
- Amir Haze🇮🇱Hadassah Medical Center
- Lilach Gavish🇮🇱 · autor de correspondenciaHebrew University of Jerusalem
- Ofer Elishoov🇮🇱Hadassah Medical Center
- Dorit Oriya Shorka🇮🇱Hadassah Medical Center
- Tamir Tsohar🇮🇱Hadassah Medical Center
- Yechiel N. Gellman🇮🇱Hadassah Medical Center
- Meir Liebergall🇮🇱Hadassah Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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