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

NCT ID: NCT06690814

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2024-11-01

Brief Summary

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.

Detailed Description

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.

Conditions

Cutaneous Ulcer Disease; Skin Sores

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ficus septica exudate

Group Type: EXPERIMENTAL

Ficus septica exudate (antiseptic plant exudates)

Intervention Type: OTHER

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).

Pterocarpus indicus exudate

Group Type: EXPERIMENTAL

Pterocarpus indicus exudate

Intervention Type: OTHER

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).

Curcuma longa aqueous extract

Group Type: EXPERIMENTAL

Curcuma longa aqueous extract

Intervention Type: OTHER

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.

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate )

Group Type: ACTIVE_COMPARATOR

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Intervention Type: DRUG

Common over the counter antiseptic cream

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ficus septica exudate (antiseptic plant exudates)

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).

Intervention Type: OTHER

Pterocarpus indicus exudate

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).

Intervention Type: OTHER

Curcuma longa aqueous extract

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.

Intervention Type: OTHER

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Common over the counter antiseptic cream

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Botanic Gardens, Kew

UNKNOWN

Sponsor Role: collaborator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vunapope Hospital

Kokopo, EAST NEW Britan, Papua New Guinea

Countries

Papua New Guinea

Other Identifiers

UlcerPlants2024

Identifier Type: -

Identifier Source: org_study_id