Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG - Second Trial (UP2025)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cutaneous Ulcer Disease; Skin Sores
• Intervention / Treatment: Other: Ficus septica exudate; Drug: Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 2

Contacts and Locations

Study Locations

• Papua New Guinea
  • EAST NEW Britan
    • Kokopo, EAST NEW Britan, Papua New Guinea
      • Vunapope Hospital, and surrounding area

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ficus septica exudate; 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).	Other: Ficus septica exudate; 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).
Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate); Common over the counter antiseptic cream	Drug: Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate); Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
No Intervention: Control; no intevention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing	A wound diameter reduction of more than 25% measured by the eKare wound imaging system.	2 weeks

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: The Royal Botanic Gardens, Kew

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2025
• Primary Completion (Actual): November 21, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: papua new guinea; sap; cutaneous ulcers; antiseptic plant; infected skin sores; Pterocarpus indicus
• Additional Relevant MeSH Terms: Immune System Diseases; Skin Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Skin Ulcer; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Trimethyl Ammonium Compounds; Cetrimonium Compounds; Cetrimonium; chlorhexidine gluconate
• Other Study ID Numbers: UlcerPlants2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request within a reasonable time-frame.
• IPD Sharing Time Frame: 2 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No