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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00709514
First received: June 27, 2008
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chronic Diabetic Foot Ulcer
Drug: DCB-WH1 ointment
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • The time of healing rate and change in ulcer area [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    time to ulcer closure, time to half ulcer closure, ulcer closure rate at endpoint, change and percentage change from baseline in ulcer size


Enrollment: 41
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 20 or older with diabetes mellitus (Type 1 or 2) who has a cutaneous ulcer on the foot and present for at least 2 weeks
  2. The target ulcer is classified as a grade 1 ulcer according to a modified Wagner system, which includes wounds involving the epidermis, the dermis, the hypodermis or the subcutaneous fat but not the tendon or joint capsule. The thickness of aforesaid layers wounds be approximately between 0.2 mm and 8 mm and is ranging in size between 3 and 15 cm2 post debridement.
  3. An ankle brachial index ≥0.80.
  4. The study ulcer should show "infection control" as judged by the investigator
  5. The subject should be free of any necrotic or infected soft and bony tissue.
  6. Signed informed consent form.

Exclusion Criteria:

  1. Ulcers caused by venous or arterial insufficiency, osteomyelitis.
  2. Poor nutritional status (albumin < 3g/dl), poor diabetic control (HbA1c > 10%), anemia (hemoglobin<10 g/dL), a leukocyte counts < 1,000/cumm.
  3. Requiring prostaglandin treatment.
  4. Requiring treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.
  5. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
  6. Presence of connective tissue disease, renal failure (*eGFR≦30 ml/min/1.73m2), abnormal liver function (Aspartate Aminotransferase(AST), Alanine Aminotransferase(ALT)>2.5x upper limit of normal range), malignancy.
  7. vascularization surgery performed <8 weeks before entry in the study.
  8. A history of cerebrovascular events, coronary intervention (stent or coronary artery bypass graft (CABG)) or myocardial infarction, within 6 months prior to study.
  9. Female patient who has a positive pregnancy test or who is breastfeeding or unwilling to use appropriate contraceptive methods during study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Taiwan
Clinical Research Division
Taipei, Taiwan, 115
Sponsors and Collaborators
Oneness Biotech Co., Ltd.
Investigators
Principal Investigator: Low-Tong Ho, MD Taipei Veterans General Hospital Taipei
  More Information

No publications provided

Responsible Party: Oneness Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT00709514     History of Changes
Other Study ID Numbers: DCB-WH1-CP001
Study First Received: June 27, 2008
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

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

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 23, 2014