A-heal® in the management of chronic nonhealing ulcers: A case series

IF 0.2 Q4 PHARMACOLOGY & PHARMACY Asian Journal of Pharmaceutical Research and Health Care Pub Date : 2022-10-01 DOI:10.4103/ajprhc.ajprhc_69_22
MdQamar Azam, Ajay Mahaputra Kumar, Nilesh Jagne
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Abstract

Background and Objective: The aim of this study is to assess the efficacy of A-Heal® in the treatment of nonhealing ulcers (NHU). Patients and Methods: This is a case–control study involving 12 patients who applied A-Heal® 10 mg twice a day on an NHU till the complete healing of the ulcer. The control group had the standard treatment. A-Heal® is a 13 amino acid chain, which was initially isolated from the human placenta, is now synthesized, and has shown to be a powerful angiogenesis factor. Before starting the trial, morphologic features of the ulcers were noted including, size, shape, location, and associated diseases. The follow-up period was set at 6 months. Results: The average age of the treated patients was 52.5 ± 5.3 years in the study group and 51.9 ± 4.7 years in the control group. The mean duration of the ulcer was 13.7 ± 5.3 weeks. All the ulcers were located in the lower limbs. In 9 (75%) patients, there was total healing of ulcers in 22 days and three patients showed signs of wound healing with a reduction in wound size and required an additional 1 week for total healing of the ulcer. Regarding the secondary outcomes of preliminary efficacy, total healing and significant reduction of the area were observed in all patients. There were no adverse events recorded. Conclusion: This case series shows that A-Heal® has proved to be safe with a good preliminary efficacy to heal NHUs, according to the protocol and doses used. A larger clinical trial is needed to verify our results.
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A-heal®在慢性不愈合溃疡治疗中的应用:一个病例系列
背景与目的:本研究的目的是评估A-Heal®治疗非愈合性溃疡(NHU)的疗效。患者和方法:这是一项病例对照研究,涉及12名患者,每天两次在NHU上应用a - heal®10毫克,直到溃疡完全愈合。对照组采用标准治疗。a - heal®是一个13个氨基酸链,最初是从人胎盘中分离出来的,现在已被合成,并已被证明是一种强大的血管生成因子。在试验开始前,记录溃疡的形态学特征,包括大小、形状、位置和相关疾病。随访时间为6个月。结果:研究组患者平均年龄52.5±5.3岁,对照组患者平均年龄51.9±4.7岁。溃疡持续时间平均为13.7±5.3周。所有溃疡均位于下肢。在9例(75%)患者中,溃疡在22天内完全愈合,3例患者表现出伤口愈合的迹象,伤口大小缩小,需要额外的1周来使溃疡完全愈合。关于初步疗效的次要结果,所有患者均观察到完全愈合和面积显着缩小。无不良事件记录。结论:该系列病例表明,根据方案和使用剂量,a - heal®已被证明是安全的,具有良好的治疗nhu的初步疗效。需要更大规模的临床试验来验证我们的结果。
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