- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624023
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
A Pilot Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Treating Lower Limb Ulcers on Patients With Diabetes Mellitus
Primary Objective:
To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers
Secondary Objective:
To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Bin-Ru She, MD,PhD
- Phone Number: 207 +886-3-5772475
- Email: binru.she@tw-bio.com
Study Locations
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-
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults at least 20 years of age.
- With diagnosed diabetic mellitus (DM), e.g. currently under DM medication treatment, or with HbA1c ≧6.5% but < 12%, or with fasting plasma glucose ≧126 mg/dL (7.0 mmol/L), or with plasma glucose ≧ 200 mg/dL (11.1 mmol/L) in the two-hour 75-gram oral glucose tolerance test (OGTT).
- With at least one cutaneous ulcer on the foot or the lower legs, and not healing for at least 4 weeks (the ≧2-week standard of care period can be counted as part of the 4-week ulcer history).
- With ankle brachial index (ABI) ≥ 0.4 on the limb with the study ulcer. For subjects with 0.6>ABI ≧0.4, the investigator will arrange for providing proper treatment to the subject, such as improving circulation by medication or surgical procedures, etc.
- The study wound is not prone to infection.
- The wound should allow complete sealing of the wound by TegadermTM film.
- The study wound size is between 1~33 cm2. The depth of wound may reach ligament, joint capsule, fascia, or tendon. There should be no sign of osteomyelitis. The wound does not exceed Wagner Grade 27.
- Under the standard care of Investigator for at least 2 weeks, the study wound has not shown significant healing. Significant healing is defined as the following: The area of healed tissue reaches at least 30% of the area of initially presented wound.
- When the subject has more than one wound which met the inclusion criteria, only one wound is selected as the study wound. The other wounds will be treated by standard cares.
- Co-morbidities are under control and non-life threatening as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
- A negative pregnancy test at Screening. This applies to any female subject with childbearing potential.
Agrees to use acceptable contraceptive methods while on study (from signing informed consent form to the end of the study). This applies to any female subject with childbearing potential and any male subject whose female partner has childbearing potential.
Acceptable contraceptive methods include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
- Able to follow the Investigator's instruction on wound care.
- With signed informed consent form.
Exclusion Criteria:
- Being pregnant or nursing.
- With autoimmune disease other than diabetes, e.g. lupus erythematosus, multiple sclerosis.
- With current malignancy or hypo-immunity.
- With history of recurrent cancer, metastatic cancer, cancer which has high probability of metastasis, or cancer on the limb where the study wound is located.
With serum chemistry abnormalities below
- AST or ALT > 5 × ULN,
- Serum albumin < 2.0 g/dL,
- With history of HIV infection
- With history of alcoholism or drug abuse.
- Received any cell-based product at the study wound.
- Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
- With any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
- With history of sensitivity to materials of bovine, porcine origin, or human serum albumin.
- With active infection or active osteomyelitis in the study wound.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TWB-103
(Mixture of TWB-102 cell and TWB-103 hydrogel)
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TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1~ Day 169
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Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically:
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Day 1~ Day 169
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Time Frame: Week 1 ~ Week 12
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Wound closure is defined as "full epithelialization of the wound with the absence of drainage and without sign of abscess under the epithelium".
An ulcer is considered healed only after wound closure is re-confirmed at the visit 2 weeks later.
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Week 1 ~ Week 12
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Time to Confirmed Wound Closure for Those Subjects Whose Wounds Are Healed During Treatment Period and During the Study Period.
Time Frame: Week 1 ~ Week 12
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Wound closure is defined as "full epithelialization of the wound with the absence of drainage and without sign of abscess under the epithelium".
An ulcer is considered healed only after wound closure is re-confirmed at the visit 2 weeks later.
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Week 1 ~ Week 12
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Change of Individual Wound Area for up to 12 Weeks.
Time Frame: Week 1~ Week 12
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The surface area of the ulcer was estimated in the manner as follows.
The ulcer along with an ulcer measuring ruler (OPSITETM transparent film) was photographed.
An OPSITETM transparent film was placed on the wound and the wound area was traced on the film.
The images were processed and analyzed using the ImageJ software package.
The ImageJ software read the computed tomographic data and calibrated the images automatically.
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Week 1~ Week 12
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Change of Wound Area at Each Week up to 12 Weeks.
Time Frame: Week 1 ~ Week 12
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The surface area of the ulcer was estimated in the manner as follows.
The ulcer along with an ulcer measuring ruler (OPSITETM transparent film) was photographed.
An OPSITETM transparent film was placed on the wound and the wound area was traced on the film.
The images were processed and analyzed using the ImageJ software package.
The ImageJ software read the computed tomographic data and calibrated the images automatically.
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Week 1 ~ Week 12
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General Granulation Rate.
Time Frame: Week 1 ~ Week 12
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The granulation rate was recorded by comments from the investigator.
Healthy granulation tissue was pink to red, moist and shiny.
Forming of healthy granulation tissue provided foundation for epithelialization and was an indicator of healing.
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Week 1 ~ Week 12
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Quality of Granulation.
Time Frame: Week 1 ~ Week 12
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The quality of granulation tissue was recorded by comments from the investigator.
Healthy granulation tissue was pink to red, moist and shiny.
Forming of healthy granulation tissue provided foundation for epithelialization and was an indicator of healing.
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Week 1 ~ Week 12
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Change of Wound Volume for Individual Subject Measured by 3D Camera and Analysis Software up to 12 Weeks.
Time Frame: Week 1 ~ Week 12
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For changes of (if data available) wound volume measured by the 3D camera from the baseline values, data was analyzed using one-sample t-test or Wilcoxon sign rank test.
(Only for those subjects who have received the 3D measurement)
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Week 1 ~ Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Niann-Tzyy Dai, PhD, Tri-Service General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-FDF-C002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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