Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG (NCT06690814) | Clinical Trial Compass
CompletedPhase 2
Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG
Papua New Guinea370 participantsStarted 2024-10-04
Plain-language 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.
Who can participate
Age range5 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Wound healing
Timeframe: 2 weeks
Trial details
NCT IDNCT06690814
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia