Reapplix today announced that it is funding a new clinical study for LeucoPatch®, on the healing of ulcers on the malleoli, a bony prominence on the ankle, which are often very hard-to-heal, due to the thin layer of tissue over this area.
LeucoPatch® improves wound healing by concentrating cells and growth factors from the patient’s own blood and applying them to their wounds. Through this, LeucoPatch® is able to accelerate healing and improve clinical outcomes.
The LiDMUS (LeucoPatch® in Diabetic Malleoli Ulcer Study) study will evaluate both the effect of LeucoPatch® on wound healing and the effect on the local wound environment.
Following encouraging results from a continuing case series by Dr Magnus Löndahl in Lund, Sweden, Reapplix will fund this new 36 patient LiDMUS Randomized Controlled Trial to assess multiple endpoints, including ulcer healing frequency, time to healing and area reduction. Wound and blood samples collected as part of the study will be analysed to confirm the mode-of-action of LeucoPatch® and further advance the scientific documentation.
The trial will be run independently by the Sponsor, Dr Magnus Löndahl, from Skåne University Hospital, Lund, Sweden and will recruit patients at centres in both Sweden and Denmark. Norddsjællands Hospital Department of Clinical Research will be the CRO for the study.
This new study is in addition to the 250 patient diabetic foot ulcer Randomized Controlled Trial that is being conducted in UK, Sweden and Denmark, which expects to report results in 2017.
Rasmus Lundquist (CSO) commented: “A key goal of Reapplix is to add to the understanding of wound healing in general and the effects of LeucoPatch® on chronic wounds specifically. Analysis of patient derived LeucoPatches and wound samples will give us great insights into the involvement of the applied leucocytes and cytokines in the transition of these very chronic wounds into healing ones. Key features are believed to be the transition of macrophages from the pro-inflammatory M1 type to the tissue-healing M2 phenotype and the involvement of LeucoPatch® derived stem cells in the healing process.”
Graeme Brookes, Chief Executive Officer at Reapplix, added: “Malleoli ulcers are difficult to treat and to heal, therefore we welcome the opportunity to test LeucoPatch® on these hard-to-heal wounds to prove that we can provide an efficacious treatment that can both reduce healthcare costs and improve patient outcomes.”