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

NCT00709514 | Completed Phase 2

• 1 other identifier: DCB-WH1-CP001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Diabetic Foot Ulcer

Keywords

Oneness; DCB-WH1; DCB-WH1-CP001; chronic; diabetic; foot ulcers; topical ointment

Outcome Measures

Primary Outcomes (1)

• The incidence of complete ulcer closure

  12 weeks

Secondary Outcomes (1)

• The time of healing rate and change in ulcer area

  12 weeks

Study Arms (2)

DCB-WH1 ointment

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

DCB-WH1 ointment DRUG

DCB-WH1 ointment (1.25%), topically applied twice daily

DCB-WH1 ointment

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• vascularization surgery performed \<8 weeks before entry in the study.
• A history of cerebrovascular 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.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

Clinical Research Division

Taipei, 115, Taiwan

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Foot Ulcer

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Low-Tong Ho, MD

  Taipei Veterans General Hospital Taipei

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 3, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

TW (1)