Chronic Diabetic Foot UlcerPhase 2NCT00709514
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
A Phase 2 study testing DCB-WH1 ointment in people with Chronic Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Diabetic Foot Ulcer
- What is being tested?
- DCB-WH1 ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
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
- Being tested
- DCB-WH1 ointment, Placebo
- Keywords
- Oneness, DCB-WH1, DCB-WH1-CP001, chronic, diabetic, foot ulcers, topical ointment
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB-WH1 ointmentDrug
DCB-WH1 ointment (1.25%), topically applied twice daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of complete ulcer closure
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oneness Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Low-Tong Ho, MD, Principal investigator, Taipei Veterans General Hospital Taipei
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709514
- Sponsor's protocol ID
- DCB-WH1-CP001
- Status last verified
- Jul 2013
- First submitted
- 27 Jun 2008
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Placebo-controlled Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00709514
- Acronym / sponsor ID
- DCB-WH1-CP001
- Conditions
- Chronic Diabetic Foot Ulcer
- Keywords
- Oneness, DCB-WH1, DCB-WH1-CP001, chronic, diabetic, foot ulcers, topical ointment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oneness Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB-WH1 ointment | Experimental | Drug: DCB-WH1 ointmentDCB-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 | Placebo comparator | Drug: PlaceboPlacebo, topical use, two times daily for 12 weeks or until ulcer closes completely or discontinuation due to treatment failure, whichever comes first. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCB-WH1 ointmentDCB-WH1 ointment (1.25%), topically applied twice daily | Drug | DCB-WH1 ointment |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The incidence of complete ulcer closure
Time frame: 12 weeks
1 secondary outcome
The time of healing rate and change in ulcer area
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
Related trials for Chronic Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Low-Tong Ho, MD principal investigator
Taipei Veterans General Hospital Taipei
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCB-WH1 ointment in people with Chronic Diabetic Foot Ulcer, run by Oneness Biotech Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of complete ulcer closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.