A Phase 2 interventional study of Ficus septica exudate (antiseptic plant exudates) and Pterocarpus indicus exudate in Cutaneous Ulcer Disease and Skin Sores, sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia. Completed at 1 site in Papua New Guinea. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Phase 2, Interventional, and Treatment
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 three readily available antibacterial plant medicines, Ficus septica, Pterocarpus indicus and Curcuma longa, comparing healing outcomes to control arms receiving Savlon antiseptic cream or no treatment. Participants with cutaneous ulcers less than 1cm in diameter will be randomized to receive topical treatment with one of three different plant medicines, Savlon cream or no treatment treatment and followed up at day 7 and 14 to assess ulcer healing and ulcer surface area.
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 we 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 three plant medicines Ficus septica, Pterocarpus indicus and Curcuma longa each comprise antibacterial plant saps which as viscous fluids 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, these plant medicines 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.
The aim of the project is to provide evidence supporting or rejecting the hypothesis that the use of one of more of these antibacterial plant medicines can improve healing or reduce the severity of small cutaneous ulcers in Papua New Guinea. Participants with ulcers less than 1cm in largest diameter will be recruited and randomised into one of five treatment arms, images and dimensions of ulcers will be recorded at baseline. Participants will receive topical treatment with one of the three plant saps, Savlon antiseptic cream or will receive no treatment. Investigators will compare healing and size of ulcers at day 7 and day 14. The study will be implemented in selected wards of East New Britain Province in Papua New Guinea.
79 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's enrollment of 370 is above the median of 44 across 65 interventional studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia is the lead sponsor of 44 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Other: Ficus septica exudate (antiseptic plant exudates)
Other: Pterocarpus indicus exudate
Other: Curcuma longa aqueous extract
Drug: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
F. septica sap contains the antibacterial alkaloid ficuseptine which exhibits activivity agaisnt S. pyogenes and H. ducreyi, two pàthogens 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).
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).
C. longa is a culinary herb that contains the antibatieral compound curcumin. Curcumin exhibits antibacterial activity agasint S. pyogenes and has profound effects on bacterial biofilms. This intervention uses a mulch of the rhizome that has been sqeeezed to produce a curcumin containing aqueous fluid.
Common over the counter antiseptic cream
Wound healing
A wound diameter reduction of more than 25% measured by the eKare wound imaging system.
Time frame: 2 weeks
Plan to share: Yes — Data will be made available upon request within a reasonable time-frame.
Supporting information: Study protocol, Sap, Icf
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia