Can a cannabis-based medicine applied to a non-healing wound improve healing and reduce pain?

ISRCTN ISRCTN16488940
DOI https://doi.org/10.1186/ISRCTN16488940
Submission date
08/03/2020
Registration date
10/03/2020
Last edited
19/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Vincent Maida
Public

Palliative Care Unit
9th Floor
101 Humber College Boulevard
Toronto
L4L 7B2
Canada

ORCiD logoORCID ID 0000-0002-8693-0617
Phone +1 416-346-6829
Email vintordoc@icloud.com

Study information

Study designProspective open-label serial case series
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeTreatment
Participant information sheet Included within the consent form
Scientific titleTopical cannabis-based medicines for wound healing and pain management
Study objectivesIntegumentary 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(s)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
Health condition(s) or problem(s) studiedIntractable non-healing wounds afflicting patients with vasculitic and vasculopathic disorders
InterventionA 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)VinSan topical cannabis-based medicines
Primary outcome measureTime to complete wound closure as reported by participants or family members
Secondary outcome measures1. 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 study start date28/05/2018
Completion date06/06/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsapproximately 30 patients
Total final enrolment42
Key inclusion criteriaIntractable, non-healing integumentary wounds of more than 6 months duration that have failed best practices and evidence-based medical treatments
Key exclusion criteria1. Declined to sign informed consent
2. Reported a prior misadventure with cannabis
3. Allergy to cannabis
Date of first enrolment06/06/2018
Date of final enrolment10/05/2019

Locations

Countries of recruitment

  • Canada

Study participating centre

Etobicoke General Hospital
101 Humber College Boulevard
Toronto
M9V 1R8
Canada

Sponsor information

William Osler Health System
Hospital/treatment centre

2100 Bovaird Drive East
Brampton
L6R 3J7
Canada

Phone +1 905-494-2120
Email Ronald.Heslegrave@williamoslerhs.ca
Website http://www.williamoslerhs.ca/
ROR logo "ROR" https://ror.org/03d1xjg58

Funders

Funder type

Industry

VinSan Therapeutics Inc

No information available

Results and Publications

Intention to publish date01/05/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe 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 planThe anonymized data in Excel files is available on request from Dr Vincent Maida (vintordoc@icloud.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 17/07/2020 17/07/2020 No No
Results article 01/09/2021 29/03/2022 Yes No
Other files Case study of 2 participants 02/09/2020 19/05/2023 No No

Additional files

ISRCTN16488940_BasicResults_17Jul2020.pdf
uploaded 17/07/2020

Editorial Notes

19/05/2023: Publication reference added.
29/03/2022: Publication reference added.
03/09/2020: The trial contact has been updated
17/07/2020: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment was added.
10/03/2020: Trial's existence confirmed by the William Osler Health System Research Ethics Board.