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

NCT07264686 | Active Not Recruiting Phase 2

• 1 other identifier: UlcerPlants2025
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cutaneous Ulcer Disease; Skin Sores

Keywords

sap; cutaneous ulcers; antiseptic plant; papua new guinea; infected skin sores; Pterocarpus indicus

Outcome Measures

Primary Outcomes (1)

• wound healing

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

  2 weeks

Study Arms (3)

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).

Other: Ficus septica exudate

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

ACTIVE COMPARATOR

Common over the counter antiseptic cream

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

Control

NO INTERVENTION

no intevention control

Interventions

Ficus septica exudate OTHER

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).

Ficus septica exudate

Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate) DRUG

Active Comparator: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Answered yes when asked if had taken antibiotics in the last week or presents with visible signs of ulcer treatment e.g. wound dressing.

Sponsors & Collaborators

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

Study Sites (1)

Vunapope Hospital, and surrounding area

Kokopo, EAST NEW Britan, Papua New Guinea

Location

MeSH Terms

Conditions

Skin Ulcer; Lymphoproliferative Disorders

Interventions

Cetrimonium; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cetrimonium Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: November 3, 2025
• Primary Completion: November 21, 2025
• Study Completion: March 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 months

Locations

PA (1)