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临床试验/NCT07264686
NCT07264686进行中(未招募)2 期

Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG- Second Trial

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2025年11月3日最近更新:
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
222
试验地点
1
主要终点
wound healing

研究概览

简要总结

Small cutaneous ulcers are common in Papua New Guinea but are normally left untreated due to lack of easy access to basic medicines. The goal of this clinical trial is to test the efficacy of a readily available antibacterial plant medicine called Pterocarpus indicus comparing healing outcomes to control arms receiving Savlon antiseptic cream and no treatment. Participants with cutaneous ulcers less than 1cm in diameter will be randomized to receive topical treatment with a plant medicines, Savlon cream or no treatment treatment and followed up at day 7 and 14 to assess ulcer healing and ulcer surface area.

详细描述

Small, infected skin ulcers are very common in children living in rural areas of Papua New Guinea (PNG) and represent a large area of unmet clinical need. These painful and debilitating ulcers often occur on the lower leg area and are suspected to be associated with a range of different bacterial pathogens including Haemophilus ducreyi and Streptococcus pyogenes. Topical antiseptics such as chlorhexidine-based antiseptic creams or antibiotics such as amoxicillin may be effective treatment options, but in rural areas of PNG, infected skin ulcers are normally left untreated due to a lack of access to such treatments. The need to walk many miles to reach an aid post, often barefoot and through swampy or muddy ground, compromises the real-world effectiveness of such treatments in PNG. In this study the investigators propose to test the effectiveness of three antibacterial traditional plant medicines, each of which has a long history of use in PNG as a plant-based topical antiseptic that is applied directly onto infected skin ulcers. The plant medicine Pterocarpus indicus is an antibacterial plant sap which as a viscous fluid can be easily applied directly onto the surface of infected ulcers. Unlike antibiotics such as amoxicillin which demand access to an aid post or clinic, this plant medicine can be easily found growing in or very near to most villages in PNG. Highly accessible, medicinal plant saps could form the basis of a cost-effective treatment option for PNG in remote areas, and may reduce the use of antibiotics. The trial proposed in this application aims to discover if such plant medicines are indeed efficacious when compared to Savlon cream or no treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Infected skin ulcer suspected with one or more predominantly moist ulcerative skin lesions of less than 1 cm diameter in greatest dimension and larger than 0.5cm in largest dimension with a predominantly moist surface, occurring below the knee.
  • Accepted and signed informed consent by a legal guardian (relative or teacher)
  • Ability and willingness to comply with the requirements of the study protocol including follow up visits.

排除标准

  • Children younger than 5 years old.
  • Ulcer presenting with a crust (not predominantly moist surface), or dimensions different to those specified in point 1 above.
  • Refusal at ward level or village chief (for village inclusion), or refusal of individual or guardian (for individual inclusion).
  • Answered yes when asked if had taken antibiotics in the last week or presents with visible signs of ulcer treatment e.g. wound dressing.

研究组 & 干预措施

Ficus septica exudate

Experimental

Description: P. indicus sap exhibits antibacterial activivity agaisnt S. pyogenes, a pàthogen associated with cutaneous ulcer disease in Papau New Guinea. The sap has been tested using the Ames test for mutagenesis, and found to be non-mutagenic; testing was carried out by toxicology service provider Gentronix, UK (results available separately on request).

干预措施: Ficus septica exudate (Other)

Control

No Intervention

no intevention control

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Active Comparator

Common over the counter antiseptic cream

干预措施: Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate) (Drug)

结局指标

主要结局

wound healing

时间窗: 2 weeks

A wound diameter reduction of more than 25% measured by the eKare wound imaging system.

次要结局

未报告次要终点

研究者

发起方
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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