Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.

The trial was open-label, so patients and clinicians knew the assigned treatment, which may have affected care and reporting. It planned 760 patients but analyzed only 129, so many subgroup questions remain uncertain. Usual care varied widely and advanced therapies were allowed in both groups; more advanced care was used in the usual care group. Baseline differences existed, including smaller average wound area in the Aurix group, 4.1 cm 2, compared with 5.6 cm 2 in the usual care group. The authors note more severe ulcers in the Aurix group. Wound durability was assessed only at a 2-week confirmation visit, and few patients returned, so long-term reopening is unknown. Enrollment was hampered by Medicare copay and reimbursement problems, and only three sites were active immediately before analysis. Safety monitoring was limited because on-site clinical monitors were not used and adverse events were spontaneously recorded. Exclusion criteria still removed patients normally seen in wound clinics, including those with serum albumin less than 2.5 g/dL, platelet count less than 100 × 10^9/L, hemoglobin less than 10.5 g/dL, malignancy in the wound area, or another wound that could interfere.

The supplied text does not include a conflicts-of-interest or funding declaration. It identifies Aurix as a Nuo Therapeutics product and repeatedly refers to a sponsor, including the sponsor's clinical specialists and operational experiences.

Do not read this as proof that Aurix gel alone healed diabetic foot ulcers. Both groups received usual wound care, advanced therapies were allowed in both groups, the study was open-label, and only 129 patients were analyzed, so the result is not proof for every clinic or patient.