Diabetic Foot Ulcers Clinical Trial
Official title:
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
Verified date | April 2019 |
Source | Skingenix, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
Status | Completed |
Enrollment | 7 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston University School of Medicine | Boston | Massachusetts |
United States | Blume Podiatry Group, P.C. | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Skingenix, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of complete healing of the target ulcer. | 8 weeks of treatment period | ||
Secondary | Time required to achieve complete healing (days). | 8 weeks treatment period | ||
Secondary | Absolute and percentage change in ulcer surface area from baseline to endpoint. | 8 weeks treatment period |
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