Cutaneous Ulcer DiseasePhase 2UP2024NCT06690814
Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG
A Phase 2 study testing Ficus septica exudate (antiseptic plant exudates), Pterocarpus indicus exudate and Curcuma longa aqueous extract 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.
Trial 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… Read more about this study
- 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 (antiseptic plant exudates), Pterocarpus indicus exudate and Curcuma longa aqueous extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 4 Oct 2024to 1 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
About this study
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.
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 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
- Being tested
- Ficus septica exudate (antiseptic plant exudates), Pterocarpus indicus exudate, Curcuma longa aqueous extract, Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)
- Keywords
- sap, cutaneous ulcers, plant sap, antiseptic plant, papua new guinea, infected skin sores
- 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 exudate (antiseptic plant exudates)Other
- 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 exudateOther
- 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 extractOther
- 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)Drug
Common over the counter antiseptic cream
| Study group | Role | What they receive |
|---|---|---|
| Ficus septica exudate | Experimental | Not described Receives: Other: Ficus septica exudate (antiseptic plant exudates) |
| Pterocarpus indicus exudate | Experimental | Not described Receives: Other: Pterocarpus indicus exudate |
| Curcuma longa aqueous extract | Experimental | Not described Receives: Other: Curcuma longa aqueous extract |
| Savlon antiseptic cream (cetrimide with chlorhexidine digluconate ) | Active comparator | Not described Receives: Drug: Savlon antiseptic cream (cetrimide with chlorhexidine digluconate) |
| Control | No intervention | Not described |
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.
- First posted15 Nov 2024
- Study start4 Oct 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
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 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Botanic Gardens, Kew
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690814
- Sponsor's protocol ID
- UlcerPlants2024
- Acronym
- UP2024
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 29 Nov 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG
- ClinicalTrials.gov ID
- NCT06690814
- Acronym / sponsor ID
- UP2024 / UlcerPlants2024
- Conditions
- Cutaneous Ulcer Disease, Skin Sores
- Keywords
- sap, cutaneous ulcers, plant sap, antiseptic plant, papua new guinea, infected skin sores
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- The Royal Botanic Gardens, Kew
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Ficus septica exudate |
| Pterocarpus indicus exudateP. 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 | Pterocarpus indicus exudate |
| Curcuma longa aqueous extractC. 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. | Other | Curcuma longa aqueous extract |
| Savlon antiseptic cream (cetrimide with chlorhexidine digluconate)Common over the counter antiseptic cream | Drug | Savlon antiseptic cream (cetrimide with chlorhexidine digluconate ) |
Primary outcome
Wound healing
Time frame: 2 weeks
A wound diameter reduction of more than 25% measured by the eKare wound imaging system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Yes. Data will be made available upon request within a reasonable time-frame.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ficus septica exudate (antiseptic plant exudates), Pterocarpus indicus exudate and Curcuma longa aqueous extract 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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.