Recce Pharmaceuticals (ASX:RCE) gained Human Research Ethics Committee approval for an amendment to its phase 3 clinical trial of Recce 327 topical gel for the potential treatment of diabetic foot infections in Australia, according to a Wednesday filing with the Australian bourse.

The amendment adds a new randomized, active-controlled, non-inferiority study arm enrolling 208 participants, which will allow the company to generate comparative clinical data for the gel against antibiotic treatment options.

The updated protocol also introduces wound imaging, which adds a further layer of objective assessment of the infection to strengthen the Recce 327 data package for global regulatory submissions, the company said.