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
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
Public
Palliative Care Unit
9th Floor
101 Humber College Boulevard
Toronto
L4L 7B2
Canada
 ORCID ID |
0000-0002-8693-0617 |
|---|---|
| Phone | +1 416-346-6829 |
| vintordoc@icloud.com |
Study information
| Study design | Prospective open-label serial case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Included within the consent form |
| Scientific title | Topical cannabis-based medicines for wound healing and pain management |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 28/05/2018 |
| Completion date | 06/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | approximately 30 patients |
| Total final enrolment | 42 |
| Key inclusion criteria | Intractable, non-healing integumentary wounds of more than 6 months duration that have failed best practices and evidence-based medical treatments |
| Key exclusion criteria | 1. Declined to sign informed consent 2. Reported a prior misadventure with cannabis 3. Allergy to cannabis |
| Date of first enrolment | 06/06/2018 |
| Date of final enrolment | 10/05/2019 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M9V 1R8
Canada
Sponsor information
Hospital/treatment centre
2100 Bovaird Drive East
Brampton
L6R 3J7
Canada
| Phone | +1 905-494-2120 |
|---|---|
| Ronald.Heslegrave@williamoslerhs.ca | |
| Website | http://www.williamoslerhs.ca/ |
"ROR" |
https://ror.org/03d1xjg58 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The 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.
