Diabetic Foot UlcerPhase 1/2NCT03624023
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
A Phase 1/2 study testing TWB-103 in people with Diabetic Foot Ulcer, run by Transwell Biotech Co., Ltd. at 2 sites in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- TWB-103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Dec 2019to 9 Jul 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10048
Tri-Service General Hospital
Taipei, 114
About this study
Official title: 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
Read the detailed description
Diabetic foot ulcers are primarily caused by poor circulation, high blood sugar (hyperglycemia), nerve damage, and foot irritation or injury. These factors, particularly poor circulation and high blood sugar, often hinder the healing process of ulcers. TWB-103 is a combination of TWB-102 cells (human fetal dermal fibroblasts) and TWB-103 hydrogel. The objective of this study was to determine whether the application of TWB-103 on diabetic ulcer wounds could accelerate the healing process in subjects with diabetic lower limb ulcers that had not shown signs of healing for at least four weeks. The study was designed as a Phase I/II, single-arm trial, with a planned enrollment of 10 subjects. These subjects would receive up to 12 weekly applications of TWB-103, and the study would evaluate both the safety and efficacy of the treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- TWB-103
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWB-103Drug
Also called Mixture of TWB-102 cell and TWB-103 hydrogel
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
| Study group | Role | What they receive |
|---|---|---|
| TWB-103 | Experimental | (Mixture of TWB-102 cell and TWB-103 hydrogel) Receives: Drug: TWB-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically:
- Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery.
- Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
Measured: Day 1~ Day 169
Secondary outcomes (7)
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
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.
Measured: Week 1 ~ Week 12
Time to Confirmed Wound Closure for Those Subjects Whose Wounds Are Healed During Treatment Period and During the Study Period.
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.
Measured: Week 1 ~ Week 12
Change of Individual Wound Area for up to 12 Weeks.
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.
Measured: Week 1~ Week 12
Change of Wound Area at Each Week up to 12 Weeks.
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.
Measured: Week 1 ~ Week 12
General Granulation Rate.
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.
Measured: Week 1 ~ Week 12
Quality of Granulation.
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.
Measured: Week 1 ~ Week 12
Change of Wound Volume for Individual Subject Measured by 3D Camera and Analysis Software up to 12 Weeks.
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)
Measured: Week 1 ~ Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start19 Dec 2019
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transwell Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niann-Tzyy Dai, PhD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624023
- Sponsor's protocol ID
- 18-FDF-C002
- Status last verified
- May 2023
- First submitted
- 1 Aug 2018
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03624023
- Acronym / sponsor ID
- 18-FDF-C002
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Transwell Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 12 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Diabetic foot ulcers are primarily caused by poor circulation, high blood sugar (hyperglycemia), nerve damage, and foot irritation or injury. These factors, particularly poor circulation and high blood sugar, often hinder the healing process of ulcers. TWB-103 is a combination of TWB-102 cells (human fetal dermal fibroblasts) and TWB-103 hydrogel. The objective of this study was to determine whether the application of TWB-103 on diabetic ulcer wounds could accelerate the healing process in subjects with diabetic lower limb ulcers that had not shown signs of healing for at least four weeks. The study was designed as a Phase I/II, single-arm trial, with a planned enrollment of 10 subjects. These subjects would receive up to 12 weekly applications of TWB-103, and the study would evaluate both the safety and efficacy of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TWB-103 | Experimental | Drug: TWB-103(Mixture of TWB-102 cell and TWB-103 hydrogel) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| TWB-103Also: Mixture of TWB-102 cell and TWB-103 hydrogelTWB-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 | Drug | TWB-103 |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1~ Day 169
Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.
7 secondary outcomes
The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.
Time frame: Week 1 ~ Week 12
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
Change of Individual Wound Area for up to 12 Weeks.
Time frame: Week 1~ Week 12
Change of Wound Area at Each Week up to 12 Weeks.
Time frame: Week 1 ~ Week 12
General Granulation Rate.
Time frame: Week 1 ~ Week 12
Quality of Granulation.
Time frame: Week 1 ~ Week 12
Change of Wound Volume for Individual Subject Measured by 3D Camera and Analysis Software up to 12 Weeks.
Time frame: Week 1 ~ Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Niann-Tzyy Dai, PhD principal investigator
Tri-Service General Hospital (TSGH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TWB-103 in people with Diabetic Foot Ulcer, run by Transwell Biotech Co., Ltd. at 2 sites 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 18 inclusion and 14 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 12 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1~ Day 169). 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 12 Jul 2023.