Woulgan Bioactive Beta-Glucan Gel is a bioactive wound product primarily for use on stalled wounds. The product contains water, glycerol, carboxymethylcellulose (CMC) and the bioactive substance soluble beta-glucan (SBG). Woulgan is a class III, rule 13 medical device, where SBG is the medicinal substance.
Woulgan Bioactive Beta-Glucan Gel is an active wound healing product containing soluble beta-glucan (SBG). The product provides an optimal moist wound-healing environment, re-hydrates necrotic tissue and aids in autolytic debridement. Woulgan is for use in stalled wounds, such as diabetic foot ulcers, leg ulcers and pressure ulcers.
The active ingredient of Woulgan Bioactive Beta-Glucan Gel is soluble beta-glucan (SBG).
SBG is an immunomodulatory compound that activates white blood cells, particularly macrophages, in the wound bed to promote more rapid healing of the wound.
Yes, Woulgan Bioactive Beta-Glucan Gel has been CE-marked as a medical device in class III under rule 13. This means that Woulgan can make claims related to the wound-healing effect of SBG in the product, distinguishing it from typical hydrogels and other wound management products. The company has a number of patents covering SBG and Woulgan.
Yes, the effect of Woulgan Bioactive Beta-Glucan Gel is well documented in preclinical models, where the ancillary medicinal effects of the soluble beta-glucan (SBG) component have been investigated and documented. In addition, the efficacy of SBG in wound healing has been documented in several clinical trials. The healing effects of SBG and Woulgan are more efficacious than those of the standard hydrogels typically used for hard-to-heal wounds.
Hydrogel dressings are 90% water in a base, a composition that promotes moist wound-healing. It is available in a variety of forms: free-flowing gel (e.g. in tubes), impregnated hydrogel (e.g. in a gauze pad or nonwoven sponge ropes/strips), or sheet hydrogel (a thin fibre mesh that holds the gel together). Like Woulgan Bioactive Beta-Glucan Gel, hydrogel dressings enhance patient comfort and aid autolytic debridement. However, hydrogels do not offer macrophage activation and the benefits of their action, because they do not contain soluble beta-glucan.
The product is intended for use in stalled wounds, such as diabetic foot ulcers, pressure ulcers, leg ulcers and burns.
Woulgan Bioactive Beta-Glucan Gel is available for purchase by healthcare professionals directly from our webshop, or via our distributors H&R Healthcare (UK), Navamedic (Nordic countries) and Rogg (Germany). Private persons may also purchase Woulgan from the webshop, but have to include the shipping address to the healthcare professional office that will be responsible for supervising the treatment.
Biotec and H&R Healthcare have applied for reimbursement in the UK. Biotec expects a typical application process to take about 6 months, and to secure final approval before the end of summer 2016. In the meantime, Woulgan Bioactive Beta-Glucan Gel is available directly from our webshop, or via H&R Healthcare.
Yes, a post-market follow-up study started in Q3 2015.