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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 <1 mg/ml, Quercetin 31.3 mg/ml, Diosmin 25.3 mg/ml, Hesperidin 2.5 mg/ml and Beta-Caryophyllene 152.7 mg/ml in the base carrier containing Hyaluronic acid + Aloe Vera Gel (1/1 v/v). Formula VS-14, applied to peri-wound, consisted of the same components but in liposomal base.
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.
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.
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.