Effectiveness of Sucralphate and Platelet-Rich Plasma Combinations For Vascular Endothelial Growth Factor (VEGF) Expression In Diabetic Ulcer Healing

Victor Jeremia Syaropi Simanjuntak, Renni Yuniati, Yan Wisnu Prajoko, Heri Nugroho Hario Seno, Tri Nur Kristina
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Abstract

Background: Diabetic ulcer is one of the most feared chronic infections due to Diabetes Mellitus because it can lead to amputation and death. Aim: To prove the effectiveness of sucralfate and platelet-rich plasma (PRP) combination for Vascular Endothelial Growth Factor (VEGF) expression in diabetic ulcer healing. Methods: This research is an experimental study of Phase I Clinical Trial with post-test only group design. There were 20 patients with diabetic ulcers divided into two groups, namely the treated group that was given sucralfate and PRP therapy and the control group was given standard therapy of normal saline drainage and gauze covered. Parameters were VEGF expression levels, wound area after being given therapy, and side effect from the treatment. Data on VEGF expression levels were obtained by means of examination with the Quantikine Human VEGF-ELISA Quantikine, R&D System, Inc, Minneapolis. The measurement of the wound area was assessed based on several criteria, namely grade 0 (no change), grade 1 (wound size reduced to less than of the previous wound), grade 2 (wound size was reduced to less than of the previous wound, but granulation was visible), and grade 3 (wound has closed completely). Result: In unpaired t-test, the mean VEGF expression was 98.18+10.96 in the treatment group and 66.69+23.79 in the control group which showed significant difference in VEGF expression levels (p = 0.003). In Mann-Whitney test, the mean wound area was 0.68+0.40 in the treatment group and 0.77+0.67 in the control group which showed that there was not any significant difference in wound area (p = 0.152). There were no side effects in both study group. Conclusions: The combination of sucralfate and PRP can increase VEGF levels significantly in diabetic ulcer patients but does not show a different effect in reducing wound area compared to standard treatment. The combination did not cause any side effects in the study subjects, as well as those using standard treatment.
琥珀酸盐和富含血小板血浆组合对糖尿病溃疡愈合中血管内皮生长因子(VEGF)表达的影响
背景:糖尿病溃疡是糖尿病患者最担心的慢性感染之一,因为它可能导致截肢和死亡。目的:证明琥珀酸盐和富含血小板的血浆(PRP)组合对糖尿病溃疡愈合中血管内皮生长因子(VEGF)表达的有效性。研究方法本研究是一项 I 期临床试验研究,采用后测分组设计。20 名糖尿病溃疡患者分为两组,治疗组给予琥珀酸盐和 PRP 治疗,对照组给予生理盐水引流和纱布覆盖的标准治疗。参数包括血管内皮生长因子表达水平、治疗后的伤口面积以及治疗的副作用。血管内皮生长因子表达水平的数据是通过明尼阿波利斯 R&D System 公司的 Quantikine Human VEGF-ELISA Quantikine 检测获得的。伤口面积的测量根据几个标准进行评估,即 0 级(无变化)、1 级(伤口面积缩小至小于之前的伤口面积)、2 级(伤口面积缩小至小于之前的伤口面积,但肉芽清晰可见)和 3 级(伤口完全闭合)。结果在非配对 t 检验中,治疗组血管内皮生长因子平均表达量为 98.18+10.96,对照组为 66.69+23.79,两组血管内皮生长因子表达水平差异显著(p = 0.003)。在曼-惠特尼检验中,治疗组的平均伤口面积为 0.68+0.40,对照组为 0.77+0.67,这表明伤口面积没有显著差异(P = 0.152)。两个研究组均无副作用。结论琥珀酸盐和 PRP 联合疗法能显著提高糖尿病溃疡患者的血管内皮生长因子水平,但与标准疗法相比,在减少伤口面积方面并无不同效果。研究对象和使用标准疗法的研究对象均未出现任何副作用。
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