Plain English Summary
Background and study aims
Wound healing is a serious problem worldwide. Non-healing wounds lead to reduced quality of life, limb amputation, increased death rates, and losses in human productivity. They can also lead to increased opioid use (and potential addiction) and antibiotic resistance. In the USA, nearly $100 billion is spent each year on on wound-related treatments, mostly on dressings that do not treat the underlying medical problems that stop the wound healing.
Wounds that do not heal are stalled in a state of extreme inflammation. The cannabis plant contains several types of anti-inflammatory chemicals. These include cannabinoids, which have been shown to reduce inflammation and enable the wound healing process to progress, as well as flavonoids and terpenes that also have positive effects on wound healing.
This study aims to investigate a topical medicine (meaning one that is applied directly to the site of the disease) based on cannabis in wounds that have not healed for 6 months or more. The treatment will be applied to the wound and around the wound. The effects on healing and pain will be measured.
Who can participate?
Adults with non-healing, deep wounds that have not healed for at least 6 months despite treatment
What does the study involve?
Participants will apply the medicine to the wound and around the wound once a day until it has healed.
What are the possible benefits and risks of participating?
There are not thought to be any side effects from the cannabis-derived ingredients of the medicine. The medicine acts at the site of the wound and is not distributed around the body to a significant extent. However, there is a small risk that application of the medicine might introduce infection into the wound.
The potential benefits are that the medicine might stimulate wound healing or reduce pain.
Where is the study run from?
William Osler Health System (Canada)
When is the study starting and how long is it expected to run for?
May 2018 to June 2019
Who is funding the study?
VinSan Therapeutics Inc (Canada), which produces the cannabis-based medicine
Who is the main contact?
Dr Vincent Maida, vintordoc@icloud.com
Trial website
Contact information
Type
Public
Primary contact
Dr Vincent Maida
ORCID ID
Contact details
Palliative Care Unit
9th Floor
101 Humber College Boulevard
Toronto
L4L 7B2
Canada
+1 416-346-6829
vintordoc@icloud.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Topical cannabis-based medicines for wound healing and pain management
Acronym
Study hypothesis
Integumentary wounds are states of dysregulation within the endogenous cannabinoid system (ECS). Topical cannabis-based medicines (TCBM), composed of proprietary mixtures of cannabinoids, terpenes, and flavonoids, are postulated to interact with the multiple elements of the ECS, and other signalling systems to restore homeostasis and thus promote integumentary wound healing and relieve wound-related pain. TCBM is applied to both the wound bed and the peri-wound integument as ECS dysregulation is present in both areas.
Ethics approval
Approved 06/06/2018, William Osler Health System Research Ethics Board (Room S.3.907, 2100 Bovaird Drive East, Brampton, Ontario, L6R 3J7, Canada; +1 (905) 494-2120 x50448; Michelle.Dimas@williamoslerhs.ca), ref: 18-0038
Study design
Prospective open-label serial case series
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Treatment
Patient information sheet
Included within the consent form
Condition
Intractable non-healing wounds afflicting patients with vasculitic and vasculopathic disorders
Intervention
A thin layer of VinSan was applied topically to both the wound bed and peri-wound integumentary tissues (approximately a 2-5 cm cuff around the wound bed) daily until complete wound closure.
Intervention type
Drug
Phase
Phase I
Drug names
VinSan topical cannabis-based medicines
Primary outcome measure
Time to complete wound closure as reported by participants or family members
Secondary outcome measures
1. Wound-related pain assessed in terms of analgesic use in daily milligram morphine equivalents (MME)
2. Wound size (longest length x widest width in cm2) measured at each clinic or home visit by the investigator or their delegate
Overall trial start date
28/05/2018
Overall trial end date
06/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Intractable, non-healing integumentary wounds of more than 6 months duration that have failed best practices and evidence-based medical treatments
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
approximately 30 patients
Participant exclusion criteria
1. Declined to sign informed consent
2. Reported a prior misadventure with cannabis
3. Allergy to cannabis
Recruitment start date
06/06/2018
Recruitment end date
10/05/2019
Locations
Countries of recruitment
Canada
Trial participating centre
Etobicoke General Hospital
101 Humber College Boulevard
Toronto
M9V 1R8
Canada
Sponsor information
Organisation
William Osler Health System
Sponsor details
2100 Bovaird Drive East
Brampton
L6R 3J7
Canada
+1 905-494-2120
Ronald.Heslegrave@williamoslerhs.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
VinSan Therapeutics Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish a series of cohort manuscripts derived from the overall case series. We intend to submit to general medicine journals, dermatology journals, and wound management journals.
IPD sharing statement:
The anonymized data in Excel files is available on request from Dr Vincent Maida (vintordoc@icloud.com).
Intention to publish date
01/05/2020
Participant level data
Available on request
Basic results (scientific)
Publication list