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家庭电刺激加速伤口愈合的双盲随机对照试验。

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

机构信息

Michael E. DeBakey Department of Surgery, Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, TX, USA.

出版信息

J Diabetes Sci Technol. 2023 Jan;17(1):15-24. doi: 10.1177/19322968211035128. Epub 2021 Jul 30.

DOI:10.1177/19322968211035128
PMID:34328024
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9846397/
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, = 16; CG, =17). At 4W, the IG showed a significant wound area reduction of 22% (BL: 7.4 ± 8.5 cm vs 4W: 5.8 ± 8.0 cm, = 0.002). Average of wound area was unchanged in the CG ( = 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.

摘要

背景

电刺激（E-Stim）可能为治疗复杂的糖尿病足溃疡（DFU）提供一种独特的辅助治疗方法。我们的主要目标是研究基于家庭的每日 E-Stim 治疗加速伤口愈合的有效性。

方法

招募患有慢性 DFU 和轻度至重度外周动脉疾病（PAD）的患者，并将其随机分为对照组（CG）或干预组（IG）。IG 每天接受 1 小时基于家庭的 E-Stim 治疗，为期 4 周（4W）。E-Stim 通过放置在踝关节上方的电贴片使用生物电刺激技术（BEST）平台（Tennant Biomodulator PRO）进行传递。CG 在同一时期使用相同但非功能性的设备。主要结果包括从基线（BL）开始的第 4 周时伤口面积减少。

结果

共招募了 38 名患者，其中 5 名因不遵守或感染而被剔除，留下 33 名参与者（IG， = 16；CG， = 17）。在第 4 周时，IG 显示出 22%的伤口面积显著减少（BL：7.4 ± 8.5 cm 对 4W：5.8 ± 8.0 cm， = 0.002）。CG 的平均伤口面积没有变化（ = 0.982）。每日家庭治疗的自我报告依从率为 93.9%。

结论

基于家庭的每日 E-Stim 提供了 E-Stim 作为辅助治疗加速慢性 DFU 和轻度至重度 PAD 患者伤口愈合的可行性、可接受性和有效性的早期结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/e8c4eaabcee3/10.1177_19322968211035128-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/3387b1ec4919/10.1177_19322968211035128-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/c4a04ee73fa7/10.1177_19322968211035128-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/997b8d3ea4cc/10.1177_19322968211035128-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/eb6ad110e84f/10.1177_19322968211035128-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/e8c4eaabcee3/10.1177_19322968211035128-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/3387b1ec4919/10.1177_19322968211035128-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/c4a04ee73fa7/10.1177_19322968211035128-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/997b8d3ea4cc/10.1177_19322968211035128-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/eb6ad110e84f/10.1177_19322968211035128-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b76/9846397/e8c4eaabcee3/10.1177_19322968211035128-fig5.jpg

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