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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

June 27, 2008
July 8, 2013
December 2008
April 2011   (final data collection date for primary outcome measure)
The incidence of complete ulcer closure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00709514 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
A Phase II, Double-blind, Placebo-controlled 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Diabetic Foot Ulcer
  • Drug: DCB-WH1 ointment
    DCB-WH1 ointment (1.25%), topically applied twice daily
  • Drug: Placebo
    Placebo
  • 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.
    Intervention: Drug: DCB-WH1 ointment
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
March 2012
April 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00709514
DCB-WH1-CP001
No
Oneness Biotech Co., Ltd.
Oneness Biotech Co., Ltd.
Not Provided
Principal Investigator: Low-Tong Ho, MD Taipei Veterans General Hospital Taipei
Oneness Biotech Co., Ltd.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP