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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

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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/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.

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Acknowledgements

We would like to thank Vladimir Heiskanen of the University of Helsinki for access to the photobiomodulation comprehensive database (http://www.bitly.com/PBM-database).

Funding

The manufacturer of the device provided active/sham devices and payment for third-party services (caregivers, statistical analysis) and provided a camera for the study. The manufacturer was not involved in the collection or analysis of the data.

Author information

Author notes

  1. Amir Haze and Lilach Gavish have contributed equally.

Authors and Affiliations

  1. Orthopedic Department, Hadassah-Hebrew University Medical Center, POB 12000, 9112001, Jerusalem, Israel

    Amir Haze, Ofer Elishoov, Dorit Shorka, Tamir Tsohar, Yechiel N. Gellman & Meir Liebergall

  2. Institute for Research in Military Medicine (IRMM) of the Faculty of Medicine, The Hebrew University of Jerusalem, POB 12272, Jerusalem, 9112001, Israel

    Lilach Gavish

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  1. Amir Haze
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Contributions

AH, OE, TT, YNG, and ML conceived the study and designed the trial; AH, OE, and TT were responsible for patient recruitment and clinical evaluations, DS was involved with the treatment and collected data, LG validated and analyzed the data, conducted literature review, and together with AH drafted the original manuscript. AH, TT, YNG, LG, and ML reviewed the manuscript critically. AH takes responsibility for the paper as a whole. All authors gave final approval for the version to be published.

Corresponding author

Correspondence to Lilach Gavish.

Ethics declarations

Ethics approval

This clinical trial (ClinicalTrials.gov: NCT01493895) was approved by the clinical trial ethical review board of The Hadassah Medical Organization (0122–11-HMO) prior to recruitment.

Consent to participate.

All patients provided written informed consent before entering the study.

Consent for publication

Figure 2 contains feet from 2 patients. The pictures were taken during 2014. Both patients are deceased; one died in 2015 and the other in 2018. The text was anonymized by omitting the exact age and gender from the legend. There is no additional identifiable data in the photos.

Data sharing

The individual measurements collected in this study and details of diabetes status and care (according to Jeffcoat et al. [3]) are reported in Supplementary Tables S1 and S2.

Conflict of interest

LG is paid as a consultant by the manufacturer of the device to give recommendations for treatment protocols. This was not relevant in this study. All other authors declare no competing interests.

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Haze, A., Gavish, L., Elishoov, O. et al. 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, 919–928 (2022). https://doi.org/10.1007/s10103-021-03335-9

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