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Abstract Title:

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.

Abstract Source:

Lasers Med Sci. 2021 May 29. Epub 2021 May 29. PMID: 34052927

Abstract Author(s):

Amir Haze, Lilach Gavish, Ofer Elishoov, Dorit Shorka, Tamir Tsohar, Yechiel N Gellman, Meir Liebergall

Article Affiliation:

Amir Haze

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/cm) 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 [cm], baseline vs endpoint: PBM 10[20.3] cmvs 0.2[2.4] cm; sham, 7.9 [12.0] cmvs 4.6 [13.8] cm, 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.

Study Type : Human Study
Additional Links
Pharmacological Actions : Anti-Ulcer Agents : CK(523) : AC(265)

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