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

Skingenix

Status and phase: Completed; Phase 2

Conditions: Diabetic Foot Ulcers

Treatments: Procedure: Standard of Care (sterile saline moistened gauze); Drug: MEBO Wound Ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154374

MEBO-DFU-PILOTII-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

MEBO Wound Ointment

Experimental group

Description:

Topical application twice daily

Treatment:

Drug: MEBO Wound Ointment

Standard of Care (sterile saline moistened gauze)

Active Comparator group

Description:

Topical application twice daily

Treatment:

Procedure: Standard of Care (sterile saline moistened gauze)