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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01154374

Enrollment

Registered

2010-06-30

Start date

2010-11-30

Completion date

2011-10-31

Last updated

2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcers

Keywords

Diabetic Foot Ulcers (DFUs)

Brief summary

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

Detailed 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.

Interventions

DRUGMEBO Wound Ointment

Topical application twice daily

PROCEDUREStandard of Care (sterile saline moistened gauze)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame
The incidence of complete healing of the target ulcer.	8 weeks of treatment period

Secondary

Measure	Time frame
Time required to achieve complete healing (days).	8 weeks treatment period
Absolute and percentage change in ulcer surface area from baseline to endpoint.	8 weeks treatment period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026