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

doi:10.1007/s10103-021-03335-9

Cited by 18 publications

(20 citation statements)

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“…So, an extensive review can bring new insights and directions about the dosimetry needed for the best results, the most promising indications, and the long- and medium-term effects for this specific population. We expect that this innovative systematic review protocol, rigorously designed by the PRISMA methodology, evaluating the literature in a very broad way with clearly defined population and objectives, will corroborate the promising results of the Haze et al study [ 1 ], bringing contributions to photobiomodulation therapy as well as to rehabilitation medicine and home care of the population with disabilities.…”

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confidence: 72%

“…It was a great pleasure to read the recent article published in Lasers in Medical Science by Haze et al [ 1 ]. This elegant study raises important points of view about at-home photobiomodulation (PBM) for the recovery of diabetic foot ulcers, one of the most important causes of disability in chronic patients.…”

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confidence: 99%

“…As per the Haze et al [ 1 ] study, previous published well-designed reviews have already pointed out that home photobiomodulation is a safe and effective technique for improving numerous clinical conditions [ 7 ]. Moreover, the COVID-19 pandemic highlights the urgency of using the home environment for the continuity of health care, which led to the publication of many studies on home-based therapies in the last 2 years.…”

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confidence: 99%

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“…Indeed, the participants of this study found the device easy to use and reported that they were likely to recommend the device even after a period of 3 months of constant use. To date, the safety and efficacy of this device have been reported for treatment of temporomandibular joint pain, 41,42 diabetic foot ulcers, 25,43,44 postoperative wounds, 45 and oral mucositis. 27,46 In this study, similar to previous studies conducted with this device, no devicerelated adverse events were reported.…”

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confidence: 99%

Photobiomodulation self‐treatment at home after rotator cuff arthroscopic repair accelerates improvement in pain, functionality, and quality of life: A double‐blind, sham‐controlled, randomized clinical trial

Abufoul,

Gavish,

Haddad

2023

Lasers Surg Med

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ObjectiveTo determine whether self‐applied photobiomodulation (PBM) therapy at home, following rotator cuff arthroscopic surgery (RCAS) can accelerate improvement in patient‐reported outcomes within the first 6 months postsurgery.MethodsThis study was a prospective, double‐blind, sham‐controlled, randomized clinical trial (NCT04593342). Patients (n = 50, age 55 ± 7 years, male:female 29:21) who underwent primary RCAS were randomized to receive active (n = 22) or sham (n = 28) PBM devices (B‐Cure Laser Pro, Erica B‐Cure LASER Ltd., Haifa, Israel) in addition to standard care. Patients self‐applied the treatments (808 nm, 15 min, 16.5 J/cm2) at home for 3 months postsurgery. Evaluations were conducted before the surgery (baseline) and at 1–3 and 6 months post‐RCAS (FU‐1M, FU‐3M, FU‐6M), and included Constant–Murley score (CMS), range of motion (ROM), subjective pain by visual analogue scale (VAS), disability by QuickDASH, and quality of life (QOL) by SF‐12. The difference from baseline to follow‐up (ΔFU), %patients achieving minimal clinical important difference (MCID), and patient acceptable symptom score (PASS) were calculated. Comparisons were conducted with superiority 2‐sample t test and χ2.ResultsBaseline values were not significantly different between groups. Both groups had similar improvements in CMS and ROM. However, compared to Sham, PBM significantly accelerated subjective pain reduction at 3 and 6 months (VAS mean ± SD, PBM‐vs‐Sham: ΔFU‐3M 32 ± 33 vs. 16 ± 27, p = 0.040; ΔFU‐6M: 41 ± 36 vs. 23 ± 26, p = 0.038), with a significantly higher proportion of patients achieving MCID at 3 months (76% vs. 48%, p = 0.027) and PASS at 6 months (48% vs. 23%, p = 0.044). PBM also significantly accelerated improvement in functionality and QOL at 6 months (QuickDASH ΔFU‐6M: 30 ± 24 vs. 18 ± 14, p = 0.029; SF‐12 physical component 6.8 ± 12.5 vs. 0.4 ± 8.6, p = 0.031; SF‐12 mental component 8.5 ± 9.1 vs. 2.2 ± 12, p = 0.032).ConclusionsSelf‐applied photobiomodulation following RCAS significantly accelerates decrease in pain and disability, and improves QOL. This nonpharmacologic add‐on therapeutic modality is easy to use and encourages active patient involvement. Its potential use in rehabilitation following other surgeries should be considered.Level of evidenceLevel I, high‐quality RCT.

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“…There is substantial animal experimental data to show that the treatment method significantly improves the healing of diabetic wounds and other chronic wounds. [139][140][141][142] Not all DFU are candidates for PBTM, and DFU patients with severe infection, ischemia, or combined systemic disease need to be excluded before using PBM. PBMT may only be significantly effective in the healing of Wagner grade 1 and 2 DFUs.…”

Section: Photobiomodulation Therapymentioning

confidence: 99%

Physical therapy in diabetic foot ulcer: Research progress and clinical application

Huang

Xin

et al. 2023

International Wound Journal

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Diabetes foot ulcer (DFU) is one of the most intractable complications of diabetes and is related to a number of risk factors. DFU therapy is difficult and involves long‐term interdisciplinary collaboration, causing patients physical and emotional pain and increasing medical costs. With a rising number of diabetes patients, it is vital to figure out the causes and treatment techniques of DFU in a precise and complete manner, which will assist alleviate patients' suffering and decrease excessive medical expenditure. Here, we summarised the characteristics and progress of the physical therapy methods for the DFU, emphasised the important role of appropriate exercise and nutritional supplementation in the treatment of DFU, and discussed the application prospects of non‐traditional physical therapy such as electrical stimulation (ES), and photobiomodulation therapy (PBMT) in the treatment of DFU based on clinical experimental records in ClinicalTrials.gov.

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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

Cited by 18 publications

References 45 publications

Comment on “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”

Comment on “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”

Photobiomodulation self‐treatment at home after rotator cuff arthroscopic repair accelerates improvement in pain, functionality, and quality of life: A double‐blind, sham‐controlled, randomized clinical trial

Physical therapy in diabetic foot ulcer: Research progress and clinical application

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