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Cannabis-Based Medicine: A Breakthrough For Healing Intractable Chronic Wounds

Chronic wounds disproportionately affect older adults, severely impairing their health and quality of life. Aging diminishes our capacity for healing, and conditions such as diabetes, vascular disease, cancer and surgical procedures put elder adults at further risk of developing chronic wounds.

While notoriously difficult to heal, a new, experimental cannabinoid-based treatment promises to vastly improve the prognosis for the millions of older adults who suffer from chronic wounds.

A Multi-Billion Dollar Market

According to the American Professional Wound Care Association, non-healing wounds impact some 15% of Medicare beneficiaries, and the costs associated with treating them can reach $30 Billion.

The anti-inflammatory properties of cannabinoids are driving investigations into potential therapies for an entire spectrum of disease states, and treatment for chronic wound healing is one of them.

Results of a recently completed study found that an experimental cannabinoid-based topical medicine achieved an extraordinary 90% success rate in healing chronic wounds. Dr. Vincent Maida, a palliative medicine specialist at the University of Toronto and principal investigator of the study, recruited thirty patients in an open-label study testing his proprietary Topical Cannabis-Based Medicines (TCBM). Twenty-seven of the participants achieved complete closure of wounds that, in some cases, had resisted healing for over a decade.

Cannabinoids for healing

Dr. Maida has been investigating cannabinoids for treating pain and wounds for over 20 years. During a graduate program on wounds at University of Toronto’s Dalla Lana School of Public Health, he encountered a pre-clinical study showing evidence of the efficacy of cannabinoids for wound healing. He recalls: “My supervisor thought I was off my rocker that I thought that cannabinoids could be effective for treating integumentary (the skin and mucous membrane system) and wound conditions. Since then the basic science has been catching up and validating all of my research.”

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He recalls: “When I started recommending cannabinoid therapies to my patients, I was considered a heretic.” But when Canada broadened the definition of medical cannabis to include extracts as well as dried botanical flower, Dr. Maida developed and patented his own formulations, and started to recruit patients for his study. He now holds what he claims to be the world’s first patents on Topical Cannabis-Based Medicines (TCBM) indicated for Integumentary and Wound Management.

The worst of the worst

Dr. Maida runs a tertiary wound clinic in the Toronto area, where he receives referrals of the most severe wounds in southern Ontario. As he explains, “Everyone else’s failures come to me. I get the worst of the worst.”

Through his recent study, he was able to subject some of those recalcitrant wounds to his innovations and intellectual property. And according to Dr. Maida, “I’m having results that are just absolutely mind-blowing.”

“I’m actually the first on record worldwide to start applying cannabis products to wounds to help with pain management, and now showing that it can heal the unhealable wounds in very elderly and sick patients. I’m literally healing wounds that otherwise people would be dying from or dying with… When I show the before and after pictures, people can’t believe that these results are real – but they are real!”

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“So if I’m able to heal the worst of the worst, imagine what my innovations can do for everyday burns and scrapes and so forth.”

Anti-inflammatory, lipophilic agents

Chronic inflammation is at the heart of a non-healing wound. Normally a wound progresses through an orderly cascade of phases from the time of initial trauma until it is fully healed. As Dr. Maida explains, wounds that don’t heal get stuck in the inflammatory stage. “There’s ample pre-clinical information already published that THC and CBD and other elements of cannabis extracts have anti-inflammatory properties. My cannabinoid-based medicines are rebooting the wound out of that chronic inflammatory stage.”

“The other thing that made me realize that wounds and cannabis were going to mix is that intact skin is hydrophilic, but a wound, on the other hand, is lipophilic. That kind of tissue can absorb THC and CBD which are also lipophilic. So it’s a perfect fit. This was one of my epiphany moments: that the very molecules that are anti-inflammatory in the cannabis extract are going to be able to be absorbed rapidly into a wound bed.”

“So everything is lining up. The endocannabinoid system (ECS) is present in the integumentary system which is the largest organ of the body. And there’s a huge opportunity to activate the ECS through the integument, and promote things like healing wounds and relieving pain from wounds – because when you heal a wound, the pain goes away.”

A partner for the next stage

At this point, Dr. Maida is looking for a partner to help take his proprietary IP to the next level, and get his products on the market to help millions of people.

According to Dr. Maida, much of the money and effort spent on treating chronic wound is in vain. “One of the areas with the worst outcomes is wounds – in terms of pain relief and healing, the results are dismal. We’re spending billions and spinning our wheels.”

Until now, Dr. Maida has self-funded the R&D of his proprietary therapies. And he believes that, seeing patients with chronic wounds week in and week out, with no prospect of improvement, was what drove him to make the personal and financial sacrifice, to give his patients hope.

The follow-up randomized controlled study is already designed and waiting. At this point, all he needs is a partner with the resources to help launch it. “It’s really what’s driving me – at a time when my colleagues are retiring, I am working on probably the greatest project in my entire career.”

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CBD for Venous Leg Ulcers: Complete Wound Closure in 81% Chronic Cases

In journalism and media industry for more than twenty years, worked for a number of media companies. Business editing, research and PR specialist. Covering industry and science news for Ilesol Pharmaceuticals.

CBD for Venous Leg Ulcers: Complete Wound Closure in 81% Chronic Cases

A new study shows that a combination of CBD, terpenes, and flavonoids improves the results of compression therapy in venous leg ulcers. With the application of the topical solution containing molecules naturally present in cannabis, the wounds rapidly healed in patients with chronic conditions. The scientists believe in the efficiency of CBD for venous leg ulcers as a promising novel supportive therapy.

Venous leg ulcers are a chronic problem in many countries, especially in Northern Europe and the US. The overall prevalence of this condition is 1% rising to 3% in patients over 65 years of age. The venous leg ulcers are formed in the skin over the ankles and often are painful. Their treatment includes standardized care, which relies on a reliable diagnosis, compression, and local wound care. The healing of these wounds is variable, with common recurrence.

A recent analysis of 1323 patients reported that the proportion of patients who achieved complete closure using compression therapy at three and six months was 42.2% and 48.6%, respectively.

A new study published in May 2021 in Experimental Dermatology shows that a combination of cannabidiol, terpenes, and flavonoids leads to rapid wound closure of previously non-healing venous leg ulcers among elderly and highly complex patients.

This prospective open-label cohort trial recruited 14 patients with 16 chronic and non-healing leg ulcers referred to a regional consultative wound management clinic in Toronto, Canada.

The median age of the patients was 75.8 years, all with chronic wounds. One 81-year old patient with a surgically fused ankle was affected by his wound for 12.2 years. More than half of the patients had moderate to severe lipodermatosclerosis, edema, and peripheral arterial disease, all of which are significant factors against wound closure.

All patients had venous leg ulcers for longer than six months that failed to close despite at least four weeks of compression therapy. All patients underwent duplex venous dopplers that confirmed the presence of venous incompetency, and wound biopsies were carried out to rule out neoplasm, vasculitis, and rare vasculopathy. All patients provided informed consent for treatment using cannabis-based medicines – VS-12 and VS-14.

The cannabis-based medicines in this trial were composed of mixtures of cannabinoids, terpenes, and flavonoids applied topically to the wound beds and peri-wound tissues. VS-12 and VS-14 were chemically equivalent but compounded in separate vehicles. Formula VS-12, applied to wound bed consisted of CBD 3.8 mg/ml, THC

CBD for venous leg ulcers: The treatment

Great results obtained in this study on CBD for venous leg ulcers resulted with the following methodology:

Treatments were carried out every second day and continued until complete wound closure,
defined as the wound bed being 100% epithelialized. On their initial visits, all patients’ degrees of global medical complexity was calculated using both the M3 multimorbidity index tool and the Palliative Performance Scale score (PPS). Qualitative clinical assessments of their degrees of lipodermatosclerosis, edema, and peripheral arterial disease were also scored and documented. Following gentle cleansing with sterile normal saline, each patient underwent application of evenly applied thin layers of VS-12 to the wound beds, and VS-14 to a 4-6 cm radial cuff of peri-wound integument every second day. Tissues were then covered with one layer each of Jelonet and Mesorb. This was followed by the application of inelastic compression bandages, chosen based upon patient preferences, using a spiral technique, between the level of the metatarsal phalangeal joints and the infra-popliteal space.

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Two-dimensional wound measurements, namely, widest width and longest length, were documented at each visit after debridement was carried out. Given the irregular and eclectic wound bed contours, the wound area calculations were approximated by matching them to various geometric shapes and applying their respective mathematical formulae. Data was also fitted to a linear regression model to report the general trend and the estimated time to complete wound closure. The observed time to complete wound closure, defined as the number of days since treatment onset to observe complete wound closure since the start of treatment, was calculated. The wound area data points were also fitted using a least-squares linear regression model. The slope was extracted to report both the absolute (cm² per 30 days) and relative (% of original wound area per 30 days) rates of wound healing. The estimated time to achieve wound healing, defined as the number of days since treatment onset for the linear fit line to reach zero was reported.

Rapid wound closure in 34 days

Complete wound closure, defined as being fully epithelialized, was achieved among 11 patients (79%) and 13 wounds (81%) within a median of 34 days. The three remaining patients were unavailable for follow-up because one of them moved out of the country, and two died of unrelated reasons. However, those three wounds also demonstrated progressive healing when last seen. There were no significant adverse reactions in any patients.

These positive outcomes are the result of potentiation and synergy between cannabinoids, terpenes, and flavonoids, the scientists conclude.

The rapid wound closure of previously non-healing venous leg ulcers among elderly and highly complex patients suggests that topical cannabis-based medicines may become effective adjuvants in conjunction with compression therapy. It may also indicate that they may have an even broader role within the skin and wound management.

Reviewed by Sasha Bajilo, founder of ILESOL Pharmaceuticals, an industrial scale producer of CBD products and formulations. Expert on Hemp/Cannabis policy, member of the Croatian Ministry of Health regulatory commission for medical cannabis.