Chronic Diabetic Foot Ulcer Clinical Trial
Official title:
A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment
in wound closure as compared to vehicle control when applied topically to chronic diabetic
foot ulcers for 12 weeks. The secondary objective of this study is to collect safety
information of DCB-WH1 ointment.
This is a randomized, double-blind, parallel group, vehicle-controlled, multi-center study
of DCB-WH1 ointment applied topically to grade 1 foot ulcers (according to Wagner grading
system) in 50 subjects with diabetes mellitus.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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