Condition category
Skin and Connective Tissue Diseases
Date applied
08/03/2020
Date assigned
10/03/2020
Last edited
10/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.williamoslerhs.ca/

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

Publication citations

Additional files

Editorial Notes

10/03/2020: Trial's existence confirmed by the William Osler Health System Research Ethics Board.