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

Oneness Biotech

Status and phase: Completed; Phase 2

Conditions: Chronic Diabetic Foot Ulcer

Treatments: Drug: DCB-WH1 ointment; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709514

DCB-WH1-CP001

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups, including a placebo group

DCB-WH1 ointment

Experimental group

Description:

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.

Treatment:

Drug: DCB-WH1 ointment

Placebo

Placebo Comparator group

Description:

Placebo, topical use, two times daily for 12 weeks or until ulcer closes completely or discontinuation due to treatment failure, whichever comes first.

Treatment:

Drug: Placebo