Clinical trial NCT00709514: Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
Official title: A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Diabetic Foot Ulcer
Keywords: Oneness
DCB-WH1
DCB-WH1-CP001
chronic
diabetic
foot ulcers
topical ointment
Lead sponsor: Oneness Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The incidence of complete ulcer closure
timeFrame: 12 weeks
Secondary outcomes:
measure: The time of healing rate and change in ulcer area
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Clinical Research Division
Study officials:
affiliation: Taipei Veterans General Hospital Taipei
name: Low-Tong Ho, MD
role: PRINCIPAL_INVESTIGATOR
References: