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

Chronic Diabetic Foot Ulcer Clinical Trial

Official title:

A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709514
• Other study ID #: DCB-WH1-CP001
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2008
• Last updated: July 8, 2013
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Oneness Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcer
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

Drug:
• DCB-WH1 ointment
DCB-WH1 ointment (1.25%), topically applied twice daily
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Clinical Research Division	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Oneness Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complete ulcer closure		12 weeks	Yes
Secondary	The time of healing rate and change in ulcer area	time to ulcer closure, time to half ulcer closure, ulcer closure rate at endpoint, change and percentage change from baseline in ulcer size	12 weeks	Yes