Origin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers.
The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, or receive standard of care as a control, to assess the safety and efficacy of plasma-generated nitric oxide, according to Origin. The company plans to treat the participants for 12 weeks and monitor them for 12 weeks following treatment.