Efficacy of Cytoreg in the treatment of diabetic foot disease.

IF 1.5 4区医学 Q3 DERMATOLOGY Journal of wound care Pub Date : 2024-11-02 DOI:10.12968/jowc.2022.0024

Darío Carrillo, Katiusca Villasana, Geizon Torres, Leonardo Dugarte, Lewis Pozo, William Bauta, William Jiménez

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Abstract

Objective: Complications from diabetic foot wounds, including bacterial infection, ulceration and gangrene, are major causes of hospitalisation and are responsible for 85% of amputations in patients with diabetes. Given that orally administered investigational therapeutic Cytoreg (Cytorex de Venezuela SA, Venezuela), a defined aqueous mixture of hydrofluoric, hydrochloric, sulfuric, phosphoric, citric and oxalic acids, has been shown to increase levels of arterial blood oxygen in a Wistar rat model, oral and oral+topical Cytoreg were tested on patients with diabetic foot ulcers (DFUs) under a humanitarian, compassionate-use protocol.

Method: All patients received oral Cytoreg (5.0 ml concentrate in fruit juice) for 30 days; half also received weekly wound washing with Cytoreg concentrate in isotonic saline (1:50 volume/volume) (oral+topical group). In addition to standard clinical observations, wounds were monitored against the Saint Elian checklist system for the diabetic foot.

Results: A total of 10 patients took part in the study. Complete wound closure was observed in 4/5 patients in the oral+topical group; in the remaining patient, necrotic and fibrin tissues on the wound edges were eliminated. Half (2/4) of the patients receiving oral-only Cytoreg experienced complete wound closure; one patient in this group was removed prematurely because of an unrelated illness and was not replaced. During the study, no significant differences were observed between groups in either the oxygen saturation of the affected tissues or in insulin and glycaemia levels (p<0.05). Significant increases in arterial haemoglobin and arterial oxygen partial pressure (p<0.05) were observed, and significant decreases were measured in the levels of glycosylated haemoglobin, aspartate aminotransferase, glutamic-pyruvic transaminase, creatine and urea (p<0.05).

Conclusion: The results of this study justify an expanded clinical study for the treatment of DFUs with Cytoreg.

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Cytoreg 治疗糖尿病足病的疗效。

目的：糖尿病足伤口并发症，包括细菌感染、溃疡和坏疽，是导致住院治疗的主要原因，也是 85% 糖尿病患者截肢的原因。鉴于口服研究性疗法 Cytoreg（Cytorex de Venezuela SA，委内瑞拉）是一种氢氟酸、盐酸、硫酸、磷酸、柠檬酸和草酸的定义水混合物，已在 Wistar 大鼠模型中被证明能提高动脉血氧水平，因此根据人道主义和同情使用协议，对糖尿病足溃疡（DFUs）患者进行了口服和口服+外用 Cytoreg 试验：方法：所有患者均接受为期 30 天的口服 Cytoreg（5.0 毫升浓缩果汁）治疗；半数患者每周还接受用等渗生理盐水（体积/体积比为 1:50）混合 Cytoreg 浓缩液清洗伤口的治疗（口服 + 局部治疗组）。除了标准的临床观察外，还根据糖尿病足圣埃利安检查表系统对伤口进行监测：共有 10 名患者参加了研究。口服+局部治疗组中有 4/5 的患者伤口完全闭合，其余患者伤口边缘的坏死组织和纤维蛋白组织已被清除。在接受纯口服 Cytoreg 的患者中，有一半（2/4）的伤口完全闭合；该组中有一名患者因患无关疾病而提前离院，未被替换。在研究期间，受影响组织的血氧饱和度或胰岛素和血糖水平在各组之间均未观察到明显差异（p 结论：这项研究的结果为扩大使用 Cytoreg 治疗 DFU 的临床研究提供了依据。

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来源期刊

Journal of wound care DERMATOLOGY-

CiteScore

2.90

自引率

10.50%

发文量

215

期刊介绍： Journal of Wound Care (JWC) is the definitive wound-care journal and the leading source of up-to-date research and clinical information on everything related to tissue viability. The journal was first launched in 1992 and aimed at catering to the needs of the multidisciplinary team. Published monthly, the journal’s international audience includes nurses, doctors and researchers specialising in wound management and tissue viability, as well as generalists wishing to enhance their practice. In addition to cutting edge and state-of-the-art research and practice articles, JWC also covers topics related to wound-care management, education and novel therapies, as well as JWC cases supplements, a supplement dedicated solely to case reports and case series in wound care. All articles are rigorously peer-reviewed by a panel of international experts, comprised of clinicians, nurses and researchers. Specifically, JWC publishes: High quality evidence on all aspects of wound care, including leg ulcers, pressure ulcers, the diabetic foot, burns, surgical wounds, wound infection and more The latest developments and innovations in wound care through both preclinical and preliminary clinical trials of potential new treatments worldwide In-depth prospective studies of new treatment applications, as well as high-level research evidence on existing treatments Clinical case studies providing information on how to deal with complex wounds Comprehensive literature reviews on current concepts and practice, including cost-effectiveness Updates on the activities of wound care societies around the world.