The Professional Education and Research Institute (PERI), a Clinical Research Organization that specializes in Phase I through Phase IV clinical trials for biologics, drugs, and devices, is grateful for the opportunity to work with Misonix Inc. now Bioventus, a global biotechnology company on the Theraskin trial recently published in the International Wound Journal (https://onlinelibrary.wiley.com/doi/10.1111/iwj.13759).
Briefly, in this Level one clinical evidence trial subjects with non-healing ulcers treated with TheraSkin in addition to Standard of Care (SOC) wound treatment had significantly improved healing versus SOC treatment alone. Alan Staley the former president of Misonix, states; “this landmark trial compliments our already existing science and publications on this unique living cell graft.”
TheraSkin is a split thickness allograft (BSA) that, in combination with SOC, has the potential to improve wound healing in Diabetic Foot Ulcers drastically.
The study " A Multi-centre prospective randomized controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers" compared the response of 100 subjects with non-healing DFUs. Fifty subjects were treated with a cryopreserved bioactive split thickness skin allograft (BSA) (TheraSkin; Bioventus) alone with appropriate standard wound treatment compared with 50 subjects treated with standard of care alone (collagen alginate dressing) for 12 weeks
The primary endpoint was the proportion of full-thickness wounds healed at 12 weeks, with secondary endpoint that include differences in percent area reduction (PAR) at 12 weeks,. The results illustrated in the intent-to-treat analysis at 12 weeks showed that 76% (38/50) of the BSA-treated DFUs healed compared with 36% (18/50) treated with SOC alone (adjusted P = .00056). In addition, the mean PAR at 12 weeks was 77.8% in the BSA group compared with 49.6% in the SOC group (adjusted P = .0019). In conclusion, adding BSA to SOC appeared to significantly improve wound healing with a lower incidence of treatment-related adverse events compared with SOC alone.
Sources:
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