A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Inclusion Criteria:

• Male or female ≥18 years of age
• Able and willing to provide informed consent
• Able and willing to comply with protocol visits and procedures
• Target ulcer duration of ≥4 weeks

Exclusion Criteria:

• Ulcer of a non-diabetic pathophysiology
• Known or suspected allergies to any of the components of MEBO
• Malignancy on target ulcer foot
• Non-compliance in the screening or run-in period