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

Primary Purpose

Chronic Diabetic Foot Ulcer

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

DCB-WH1 ointment

Placebo

About this trial

This is an interventional treatment trial for Chronic Diabetic Foot Ulcer focused on measuring Oneness, DCB-WH1, DCB-WH1-CP001, chronic, diabetic, foot ulcers, topical ointment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Clinical Research Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DCB-WH1 ointment

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

The incidence of complete ulcer closure

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00709514

First Posted

June 27, 2008

Last Updated

July 8, 2013

Sponsor

Oneness Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00709514

Brief Title

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

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oneness Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Diabetic Foot Ulcer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCB-WH1 ointment

Arm Type

Experimental

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

DCB-WH1 ointment

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

The incidence of complete ulcer closure

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The time of healing rate and change in ulcer area

Description

time to ulcer closure, time to half ulcer closure, ulcer closure rate at endpoint, change and percentage change from baseline in ulcer size

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Low-Tong Ho, MD

Organizational Affiliation

Taipei Veterans General Hospital Taipei

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Division

City

Taipei

ZIP/Postal Code

115

Country

Taiwan

12. IPD Sharing Statement

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

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