ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

This study is currently recruiting participants.
Verified by Oneness Biotech Co., Ltd., June 2008

Sponsored by: Oneness Biotech Co., Ltd.
Information provided by: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT00709514
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Oneness Biotech Co., Ltd.:

Primary Outcome Measures:
  • The incidence of complete ulcer closure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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
2: Placebo Comparator Drug: Placebo
Placebo

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Ages 20 or older with diabetes mellitus (Type 1 or 2) who has a cutaneous ulcer on the foot and present for at least 4 weeks
  • The target ulcer is classified as a grade 1 ulcer according to Wagner system and is ranging in size between 3 and 15 cm2 post debridement.
  • An ankle brachial index ≥0.80.
  • The study ulcer should show "infection control" as judged by the investigator
  • The subject should be free of any necrotic or infected soft and bony tissue.
  • Signed informed consent form.

Exclusion Criteria:

  • Ulcers caused by venous or arterial insufficiency, osteomyelitis.
  • Poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 10%), anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/cumm.
  • Requiring prostaglandin treatment.
  • Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.
  • Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
  • resence of connective tissue disease, renal failure (serum creatinine > 1.5 mg/dl), abnormal liver function (AST, ALT>2.5x upper limit of normal range), malignancy.
  • vascularization surgery performed <8 weeks before entry in the study.
  • Proliferative retinopathy, pre-proliferative retinopathy.
  • A history of cerebravascular events, coronary intervention (stent or coronary artery bypass graft (CABG)) or myocardial infarction, within 6 months prior to study.
  • Female patient who has a positive pregnancy test or who is breastfeeding or unwilling to use appropriate contraceptive methods during study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709514

Contacts
Contact: David Yeh, MS     886226558558 ext 306     davidyeh@microbio.com.tw    
Contact: Peter Pan, MS     886226558558 ext 311     peterpan@microbio.com.tw    

Locations
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.            

Sponsors and Collaborators
Oneness Biotech Co., Ltd.

Investigators
Principal Investigator:     Low-Tong Ho, MD     Taipei Veterans General Hospital Taipei    
  More Information


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

Keywords provided by Oneness Biotech Co., Ltd.:
microbio  
DCB-WH1  
DCB-WH1-CP001  
chronic  
diabetic
foot ulcers
topical ointment

Study placed in the following topic categories:
Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008




Links to all studies - primarily for crawlers