drugset / Trial / NCT00709514

Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

NCT00709514 ↗

Phase 2 Completed 41 enrolled Oneness Biotech Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2008-12
Primary completion
2011-04
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject DCB-WH1 Unknown 1.25 % Topical

Indications