Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial

Alejandro Zulbaran-Rojas; Catherine Park; Nesreen El-Refaei; Brian Lepow; Bijan Najafi

doi:https://doi.org/10.1177/19322968211035128

Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial

Alejandro Zulbaran-Rojas, Catherine Park, Nesreen El-Refaei, Brian Lepow, Bijan Najafi

Surgery

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

Background: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. Methods: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST^®) platform (Tennant Biomodulator^® PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). Results: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm² vs 4W: 5.8 ± 8.0 cm², P = 0.002). Average of wound area was unchanged in the CG (P = 0.982). The self-report adherence to daily home-therapy was 93.9%. Conclusions: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.

Original language	English (US)
Pages (from-to)	15-24
Number of pages	10
Journal	Journal of Diabetes Science and Technology
Volume	17
Issue number	1
DOIs	https://doi.org/10.1177/19322968211035128
State	Published - Jan 2023

Keywords

amputation
diabetic foot ulcer
electrical stimulation
home-based therapy
limb salvage
neuromodulation
skin perfusion
tissue oxygenation
wearables
wound healing

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism
Bioengineering
Biomedical Engineering

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https://doi.org/10.1177/19322968211035128

Cite this

@article{b4daec8c86bd462ea44cab4f16209d39,

title = "Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial",

abstract = "Background: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. Methods: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST{\textregistered}) platform (Tennant Biomodulator{\textregistered} PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). Results: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm2 vs 4W: 5.8 ± 8.0 cm2, P = 0.002). Average of wound area was unchanged in the CG (P = 0.982). The self-report adherence to daily home-therapy was 93.9%. Conclusions: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.",

keywords = "amputation, diabetic foot ulcer, electrical stimulation, home-based therapy, limb salvage, neuromodulation, skin perfusion, tissue oxygenation, wearables, wound healing",

author = "Alejandro Zulbaran-Rojas and Catherine Park and Nesreen El-Refaei and Brian Lepow and Bijan Najafi",

note = "Funding Information: We thank Jeffrey Ross, DPM, MD, for patient care and referral of this study. We thank Hector Elizondo-Adamchik, MD, Anmol Momin, BS, Naima Rodriguez, MA, Sogol Golafshan, BS, and Alan Pham, BS, for assisting with data collection and coordination of this research study between involved key investigators. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported in part by a grant from AVAZZIA Inc., (Dallas, TX, US). The sponsor did not have any role in designing the study, recruiting the participants, analysing the data, or interpretation of results. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported in part by a grant from AVAZZIA Inc., (Dallas, TX, US). The sponsor did not have any role in designing the study, recruiting the participants, analysing the data, or interpretation of results. Publisher Copyright: {\textcopyright} 2021 Diabetes Technology Society.",

year = "2023",

month = jan,

doi = "https://doi.org/10.1177/19322968211035128",

language = "English (US)",

volume = "17",

pages = "15--24",

journal = "Journal of diabetes science and technology",

issn = "1932-2968",

publisher = "Diabetes Technology Society",

number = "1",

}

TY - JOUR

T1 - Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial

AU - Zulbaran-Rojas, Alejandro

AU - Park, Catherine

AU - El-Refaei, Nesreen

AU - Lepow, Brian

AU - Najafi, Bijan

N1 - Funding Information: We thank Jeffrey Ross, DPM, MD, for patient care and referral of this study. We thank Hector Elizondo-Adamchik, MD, Anmol Momin, BS, Naima Rodriguez, MA, Sogol Golafshan, BS, and Alan Pham, BS, for assisting with data collection and coordination of this research study between involved key investigators. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported in part by a grant from AVAZZIA Inc., (Dallas, TX, US). The sponsor did not have any role in designing the study, recruiting the participants, analysing the data, or interpretation of results. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported in part by a grant from AVAZZIA Inc., (Dallas, TX, US). The sponsor did not have any role in designing the study, recruiting the participants, analysing the data, or interpretation of results. Publisher Copyright: © 2021 Diabetes Technology Society.

PY - 2023/1

Y1 - 2023/1

N2 - Background: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. Methods: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST®) platform (Tennant Biomodulator® PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). Results: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm2 vs 4W: 5.8 ± 8.0 cm2, P = 0.002). Average of wound area was unchanged in the CG (P = 0.982). The self-report adherence to daily home-therapy was 93.9%. Conclusions: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.

AB - Background: Electrical stimulation (E-Stim) may offer a unique adjunctive treatment to heal complicated diabetic foot ulcers (DFU). Our primary goal is to examine the effectiveness of daily home-based E-Stim therapy to speed-up wound healing. Methods: Patients with chronic DFUs and mild to severe peripheral arterial disease (PAD) were recruited and randomized to either control (CG) or intervention (IG) groups. The IG received 1-hour home-based E-Stim therapy on daily basis for 4 weeks (4W). E-Stim was delivered through electrical pads placed above the ankle joint using a bio-electric stimulation technology (BEST®) platform (Tennant Biomodulator® PRO). The CG was provided with an identical but non-functional device for the same period. The primary outcome included wound area reduction at 4W from baseline (BL). Results: Thirty-eight patients were recruited and 5 were removed due to non-compliance or infection, leaving 33 participants (IG, n = 16; CG, n =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm2 vs 4W: 5.8 ± 8.0 cm2, P = 0.002). Average of wound area was unchanged in the CG (P = 0.982). The self-report adherence to daily home-therapy was 93.9%. Conclusions: Daily home-based E-Stim provides early results on the feasibility, acceptability, and effectiveness of E-Stim as an adjunctive therapy to speed up wound healings in patients with chronic DFU and mild to severe PAD.

KW - amputation

KW - diabetic foot ulcer

KW - electrical stimulation

KW - home-based therapy

KW - limb salvage

KW - neuromodulation

KW - skin perfusion

KW - tissue oxygenation

KW - wearables

KW - wound healing

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U2 - https://doi.org/10.1177/19322968211035128

DO - https://doi.org/10.1177/19322968211035128

M3 - Article

SN - 1932-2968

VL - 17

SP - 15

EP - 24

JO - Journal of diabetes science and technology

JF - Journal of diabetes science and technology

IS - 1

ER -

Home-Based Electrical Stimulation to Accelerate Wound Healing—A Double-Blinded Randomized Control Trial

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