Truheal

A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.

This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers.
HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area.
* The primary end point of this study is assessment of safety in treating with HO/03/03 and the efficacy of the drug to promote wound closure of chronic wounds.
* The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression.