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

NCT06690814 | Completed Phase 2

• 1 other identifier: UlcerPlants2024
• Study Type: interventional
• Target: 370
• 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 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.

Conditions

Cutaneous Ulcer Disease; Skin Sores

Keywords

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

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 (5)

Ficus septica exudate

EXPERIMENTAL

Other: Ficus septica exudate (antiseptic plant exudates)

Pterocarpus indicus exudate

EXPERIMENTAL

Other: Pterocarpus indicus exudate

Curcuma longa aqueous extract

EXPERIMENTAL

Other: Curcuma longa aqueous extract

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate )

ACTIVE COMPARATOR

Drug: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)

Control

NO INTERVENTION

Interventions

Ficus septica exudate (antiseptic plant exudates) 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).

Ficus septica exudate

Pterocarpus indicus exudate 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).

Pterocarpus indicus exudate

Curcuma longa aqueous extract 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.

Curcuma longa aqueous extract

Savlon antiseptic cream (cetrimide with chlorhexidine digluconate) DRUG

Common over the counter antiseptic cream

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

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

Study Sites (1)

Vunapope Hospital

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 we propose is an evaluator-blinded, randomized clinical trial to compare the effects of topical application of three traditional medicine plant saps compared to Savlon cream or no treatment: (A) Ficus septica plant sap (50μl) applied topically at baseline, day 3 and day 7. (B) Pterocarpus indicus plant sap (50μl) applied topically at baseline, day 3 and day 7. (C) Curcuma longa plant sap (50μl) applied topically at baseline, day 3 and day 7. (D) Savlon cream (200mg) applied topically at baseline, day 3 and day 7. (E) No treatment.

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: October 4, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

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

Locations

PA (1)