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.
|Chronic Diabetic Foot Ulcer||Drug: DCB-WH1 ointment Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers|
- The incidence of complete ulcer closure [ Time Frame: 12 weeks ]
- The time of healing rate and change in ulcer area [ Time Frame: 12 weeks ]time to ulcer closure, time to half ulcer closure, ulcer closure rate at endpoint, change and percentage change from baseline in ulcer size
|Study Start Date:||December 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: DCB-WH1 ointment
DCB-WH1 ointment 1.25%, topical use, two times daily for 12 weeks or until ulcer closes completely or discontinuation due to treatment failure, whichever comes first.
Drug: DCB-WH1 ointment
DCB-WH1 ointment (1.25%), topically applied twice daily
Placebo Comparator: Placebo
Placebo, topical use, two times daily for 12 weeks or until ulcer closes completely or discontinuation due to treatment failure, whichever comes first.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709514
|Clinical Research Division|
|Taipei, Taiwan, 115|
|Principal Investigator:||Low-Tong Ho, MD||Taipei Veterans General Hospital Taipei|