Osiris Therapeutics begins phase III trial of OTI-15-01 for treatment of diabetic foot ulcers

A DFU is an open sore that affect the heel, toes, top, or bottom of the foot, which usually starts as a cut and can get bigger over time.

OTI-15-01 is the placental technology product that is being developed as an investigational new drug intended to heal wounds in patients suffering from chronic DFUs.

The company will enroll around 224 patients at around 20 sites in the randomized, controlled and blinded study, which also has open-label extension option.

In the trial, the firm will randomize the patients to receive OTI-15-01 plus standard of care against standard of care alone, which includes debridement, non-adherent dressing and standardized off-loading.

According to the firm, the primary endpoint is the proportion of patients with complete wound healing by week 12, with confirmation of durability of complete wound healing during two subsequent visits two weeks apart.

The secondary endpoints of the trial comprise of time to healing, week four wound size reduction, number of applications and overall safety, including wound specific adverse events.

Osiris Therapeutics president and CEO Dr Lode Debrabandere said: "This next generation product meets the highest quality standards for a biologic, and contains consistent amounts of viable, potent cells.

"We believe that delivering these directly to the wound bed is the best approach for patients who are suffering from chronic non-healing diabetic foot ulcers."