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Sponsored by: |
Oneness Biotech Co., Ltd. |
Information provided by: | Oneness Biotech Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00709514 |
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WHI 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-WHI 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 40 subjects with diabetes mellitus.
Condition | Intervention | Phase |
Chronic Diabetic Foot Ulcers |
Drug: DCB-WH1 ointment Drug: Placebo |
Phase II |
MedlinePlus related topics: | Diabetic Foot Foot Health |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blind, Placebo-Controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers |
Estimated Enrollment: | 40 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: DCB-WH1 ointment
DCB-WH1 ointment (1.25%), topically applied twice daily
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Yeh, MS | 886226558558 ext 306 | davidyeh@microbio.com.tw |
Contact: Peter Pan, MS | 886226558558 ext 311 | peterpan@microbio.com.tw |
Taiwan | |||||
Clinical Research Division | Recruiting | ||||
Taipei, Taiwan, 115 | |||||
Contact: David Yeh, Director 886226558558 ext 306 davidyeh@microbio.com.tw | |||||
Principal Investigator: Low-Tong Ho, M.D. |
Oneness Biotech Co., Ltd. |
Principal Investigator: | Low-Tong Ho, MD | Taipei Veterans General Hospital Taipei |
Responsible Party: | Microbio Co., Ltd. ( Mr. David Yeh/ Director, Clinical Research ) |
Study ID Numbers: | DCB-WH1-CP001 |
First Received: | June 27, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00709514 |
Health Authority: | United States: Food and Drug Administration |
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