Clinical and Histological Outcomes of Negatively Charged Polystyrene Microspheres Applied Daily Versus Three Times per Week in Hard-to-Heal Diabetic Foot Ulcers: A Randomized Blinded Controlled Trial.

IF 3.6 2区 心理学 Q1 EDUCATION & EDUCATIONAL RESEARCH
Educational Psychology Pub Date : 2025-06-01 Epub Date: 2022-05-29 DOI:10.1177/15347346221104946
José Luis Lázaro-Martínez, Marta García-Madrid, Mateo López-Moral, Aroa Tardáguila-García, Francisco Javier Álvaro-Afonso, Yolanda García-Álvarez
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Abstract

Negatively charged polystyrene microspheres (NCMs) have been demonstrated as a novel and effective therapy for managing hard-to-heal diabetic foot ulcers (DFUs). However, one limitation of this therapy is that the protocol is based on daily application, which sometimes does not fit local protocols of wound care. Thus, we aimed to analyze the safety and efficacy of a new dose regimen. We conducted a randomized blinded controlled trial in a specialized diabetic foot unit between May 2019 and February 2021 with a total of 30 patients who had neuropathic or neuroischemic DFUs that had not responded after four weeks of standard treatment. Patients were randomized consecutively into a group that received daily application (control) or one that received applications three times per week (experimental). The clinical outcomes were evaluated using the Wollina score and wound-area reduction (WAR) weekly during a treatment period of 28 days. The histological outcomes were assessed using a soft-tissue punch biopsy (3 mm) at 0, 14, and 28 days to evaluate cellular proliferation. The Wollina scores were higher at the end of treatment by week 4 in both groups, but the differences were not significant between groups. The averages were 6 (5, 7) points in Experimental group (EG) and 6 (6,7) points in Control group (CG) (p = 0.848). Wound area reduction at day 28 was 53.57 [37.43, 79.16] % in the CG and 79.37 [42.74, 93.57] % in the EG, without differences among groups (p = 0.305). Cellular proliferation was similar in both groups at day 28. Application three times per week showed similar clinical and histological outcomes to those of daily application, both dose regimens demonstrated significant improvement of granulation tissue formation and WAR during the treatment.

负电荷聚苯乙烯微球对难愈合糖尿病足溃疡的临床和组织学疗效:随机盲法对照试验。
带负电荷的聚苯乙烯微球(NCMs)已被证明是治疗难以愈合的糖尿病足溃疡(DFUs)的一种新型有效疗法。然而,这种疗法的一个局限性是,其治疗方案以每日应用为基础,有时并不适合当地的伤口护理方案。因此,我们旨在分析新剂量方案的安全性和有效性。2019 年 5 月至 2021 年 2 月期间,我们在糖尿病足专科病房开展了一项随机盲法对照试验,共收治了 30 名接受标准治疗四周后仍无反应的神经性或神经缺血性 DFU 患者。患者被连续随机分为每天用药组(对照组)和每周用药三次组(实验组)。在 28 天的治疗期间,每周使用 Wollina 评分和伤口面积缩小(WAR)来评估临床结果。在 0、14 和 28 天时,使用软组织冲孔活检(3 毫米)对组织学结果进行评估,以评价细胞增殖情况。治疗结束第 4 周时,两组的 Wollina 评分均有所提高,但组间差异不显著。实验组(EG)的平均值为 6(5,7)分,对照组(CG)的平均值为 6(6,7)分(P = 0.848)。第 28 天,CG 和 EG 的伤口面积缩小率分别为 53.57 [37.43, 79.16] % 和 79.37 [42.74, 93.57]%,组间无差异(p = 0.305)。第 28 天时,两组的细胞增殖情况相似。每周施用三次的临床和组织学结果与每天施用的结果相似,两种剂量方案在治疗期间都能显著改善肉芽组织的形成和WAR。
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来源期刊
CiteScore
6.40
自引率
6.20%
发文量
57
期刊介绍: This journal provides an international forum for the discussion and rapid dissemination of research findings in psychology relevant to education. The journal places particular emphasis on the publishing of papers reporting applied research based on experimental and behavioural studies. Reviews of relevant areas of literature also appear from time to time. The aim of the journal is to be a primary source for articles dealing with the psychological aspects of education ranging from pre-school to tertiary provision and the education of children with special needs. The prompt publication of high-quality articles is the journal"s first priority. All contributions are submitted "blind" to at least two independent referees before acceptance for publication.
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