Cutaneous Ulcer DiseasePhase 2UP2025NCT07264686

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

A Phase 2 study testing Ficus septica exudate and Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate) in people with Cutaneous Ulcer Disease and Skin Sores, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Papua New Guinea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 5 to 17 years
Conditions the study is for: Cutaneous Ulcer Disease, Skin Sores
What is being tested?: Ficus septica exudate and Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 1 sitePapua New Guinea
Study dates: 3 Nov 2025to 30 Sep 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Papua New Guinea1 site

Vunapope Hospital, and surrounding area
Kokopo, EAST NEW Britan

Other trials in Papua New Guinea

About this study

Official title: 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.

Read the 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.

Conditions: Cutaneous Ulcer Disease, Skin Sores
Being tested: Ficus septica exudate, Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
Keywords: sap, cutaneous ulcers, antiseptic plant, papua new guinea, infected skin sores, Pterocarpus indicus
Medical subject headings: Skin Ulcer, Lymphoproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ficus septica exudateOther
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)Drug
Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Study groups in NCT07264686
Study group	Role	What they receive
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). Receives: Other: Ficus septica exudate
Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)	Active comparator	Common over the counter antiseptic cream Receives: Drug: Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
Control	No intervention	no intevention control

What is being measured

The primary outcome is the main question the study is designed to answer.

wound healing
A wound diameter reduction of more than 25% measured by the eKare wound imaging system.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202530 Sep 2026

First posted4 Dec 2025
Study start3 Nov 2025
Primary completion21 Nov 2025
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cutaneous Ulcer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study proposed is an evaluator-blinded, randomized clinical trial to compare the effects of topical application of a traditional medicine plant sap compared to Savlon cream and no treatment: (A) Pterocarpus indicus plant sap (50μl) applied topically at baseline and for four more days (B) Savlon cream (200mg) applied topically at baseline and for four more days (C) No treatment
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 222 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07264686
Sponsor's protocol ID: UlcerPlants2025
Acronym: UP2025
Status last verified: Jul 2026
First submitted: 24 Nov 2025
Last updated: 16 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be made available upon request within a reasonable time-frame.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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