An Accessible Low-cost Plant Treatment for Cutaneous Ulcers

Overview

In a search for accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identify the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. This is an open label clinical trial using an interventional approach, to compare the effect of the antiseptic plant sap and standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 22, 2019

Detailed Description

The cutaneous ulcer is a painful and debilitating bacterial infection that is common in rural areas of Papua New Guinea (PNG). Systematic treatment with topical antiseptics such as chlorhexidine cream in theory represents a viable treatment option, but in reality, effective treatment of cutaneous ulcers in Papua New Guinea is greatly hindered by the remote and highly inaccessible areas that affected communities often live in. In a search for more accessible treatment options, plant medicines used by different communities in Papua New Guinea have been tested to identified the sap of the tree, Ficus septica, as a promising antibacterial agent in vitro. The sap displays comparable activity to chlorhexidine in disc diffusion assays with gram-positive bacterial wound pathogens. It also appears to dampen the pro-inflammatory responses of neutrophils by down regulating interleukin-6 expression. The sap forms a flexible plastic-like wound covering which may help deter flies from feeding on the wounds, and unlike chlorhexidine cream, the Ficus tree is easy to find where affected communities live. For this reason, this study aims to perform an open label clinical trial using an interventional approach, to compare the effect of this antiseptic plant sap and of a standard topical antiseptic, on the rate of wound development prevention and bacterial growth. If shown to be effective, this readily available plant medicine can provide a zero-cost treatment option in remote areas of PNG.

Interventions

  • Biological: Topical antiseptic treatment
    • Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.

Arms, Groups and Cohorts

  • No Intervention: Soap and Water
    • Standard of care using soap and water
  • Experimental: Ficus Septica Sap
    • Ficus Septica Sap, topical cream, 50ul, daily, for 2 days
  • Active Comparator: Chlorhexidine (Topical)
    • Chlorhexidine, topical solution, 50ul, daily, for 2 days

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with Clinical Healing in each arm
    • Time Frame: 21 days
    • surface reduction by more than 50%
  • Number of participants with Clinical Healing in each arm
    • Time Frame: 21 days
    • Ulcer healing determined by a professional dermatologist, described as as: appearance of granulation tissue, healed borders, dry ulcer, no exudation.

Secondary Measures

  • Changes in wound microbiology
    • Time Frame: 21 days
    • Up to five key pathogens identified by next generation sequencing of wound fluids will be quantified at Day 0 and at Day 21 for samples from each arm of the study

Participating in This Clinical Trial

Inclusion Criteria

-children aged 5 to 15 with parental consent and with one or more skin breaks of any nature (i.e. Skin cuts, scratch, scrapes or abrasion and mosquito bites) that are less than 1cm in major diameter. Written informed consent by parent or guardian will be required before enrolment. Exclusion Criteria:

:

  • All participants who have received medical treatment for skin ulcers up to 2 months prior to recruitment (azithromycin, amoxicillin, benzathine penicillin, etc.). – Patients who require antibiotic treatment for another condition not-related to the study. – Known history of hypersensitivity, allergic or adverse reaction to the study product. – Patients presenting cutaneous ulcer more than 1cm

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oriol Mitja
  • Collaborator
    • The University of Papua New Guinea
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Oriol Mitja, Dr. Oriol Mitja – Lihir Medical Centre

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