Diabetic Foot UlcerPhase 1NCT05165628
Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers
A Phase 1 study testing CYP-006TK in people with Diabetic Foot Ulcer and Cutaneous Ulcer, run by Cynata Therapeutics Limited at 4 sites in Australia.
Trial summary
Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Cutaneous Ulcer
- What is being tested?
- CYP-006TK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesAustralia
- Study dates
- 4 Jan 2022to 24 Sep 2024
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age up to 80 years of age, inclusive.
- Have a current diagnosis of diabetes mellitus (DM)
- With at least one non-healing cutaneous ulcer on the foot or the lower legs
- With ankle brachial index (ABI) ≥ 0.4 and/or toe pressure >30 mmHg on the limb with the study ulcer.
- Participant co-morbidities are adequately managed, and the participant has a life expectancy of at least 6 months as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
- A negative pregnancy test, (i.e. for female participants with childbearing potential).
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- Willing to comply with birth control measures, to prevent female participants becoming pregnant for six months following administration of the study treatment.
- Able to follow the Investigator's instruction on ulcer care (in the opinion of the Investigator).
- Agrees to provide written informed consent.
Who cannot join
- Planned vascular surgery, angioplasty, thrombolysis or amputation of the affected limb in the next six months.
- Pregnant or breastfeeding.
- Active infection in the study ulcer.
- Any sign of osteomyelitis associated with the study ulcer.
- Study ulcer extends to bone or periosteum (ulcers that reach a ligament, joint capsule, fascia, or tendon are not excluded).
- Study ulcer requires daily dressing changes.
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- Known autoimmune disease other than diabetes, including but not limited to lupus erythematosus, multiple sclerosis which are considered as clinically significant by PI and/or Medical Monitor.
- Treatment with systemic immunosuppressants within 90 days of screening.
- Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
- Serum GGT, AST or ALT > 5 × upper limit of the normal range (ULN).
- . Known history of HIV infection
- Prior administration of any cell-based treatment to the limb affected by the study ulcer.
- Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned initiation of study treatment.
- Any other medical condition or laboratory abnormality judged as clinically significant by the Investigator or study Medical Monitor which could confound the evaluation of the trial treatment.
- With history of sensitivity to materials of bovine, porcine origin, or human serum albumin.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Central Adelaide Local Health Network
Adelaide, South Australia, 5000
Fiona Stanley Hospital
Perth, Western Australia
Royal Perth Hospital
Perth, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia
About this study
Official title: A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers
Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers.
The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups:
Read more
- Group 1: CYP-006TK
- Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation.
Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study.
Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.
- Conditions
- Diabetic Foot Ulcer, Cutaneous Ulcer
- Being tested
- CYP-006TK
- Medical subject headings
- Diabetic Foot, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP-006TKCombination product
CYP-006TK is allogenic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs) or Cymerus™ MSCs, seeded onto a heptylamine plasma polymer-coated silicone dressing
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - CYP-006TK | Experimental | Participants will receive CYP-006TK dressings Receives: Combination Product: CYP-006TK |
| Group 2 - Standard of Care | No intervention | Participants will continue to be treated as per local standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: 24 weeks
Incidence of changes from baseline in haematology, biochemistry, and urinalysis parameters.
Results will be summarised by individual and by treatment group using descriptive statistics.
Measured: 24 weeks
Secondary outcomes (9)
Percentage of area change of study ulcer from baseline to weeks 12 and 24
Measured: 12 and 24 weeks
Number of days to complete ulcer healing
Measured: 12 and 24 weeks
Number of days to 50% ulcer healing
Measured: 12 and 24 weeks
Percentage change in ulcer volume from baseline to weeks 12 and 24
Measured: 12 and 24 weeks
Changes from baseline in ulcer pain assessed using a Numeric Rating Scale
Measured: 12 and 24 weeks
Number clinic/home care visits across groups
Measured: 12 and 24 weeks
Differences across groups on ulcer dressing products used
Measured: 12 and 24 weeks
Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule
Measured: 12 and 24 weeks
Duration of clinic/home care visits across groups
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start4 Jan 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynata Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jolanta Airey, MD, Study director, Cynata Therapeutics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165628
- Sponsor's protocol ID
- CYP-DFU-P1-01
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2021
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05165628
- Acronym / sponsor ID
- CYP-DFU-P1-01
- Conditions
- Diabetic Foot Ulcer, Cutaneous Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cynata Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 21 Dec 2021 (actual)
- 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.
Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers.
The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups:
- Group 1: CYP-006TK
- Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation.
Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study.
Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - CYP-006TK | Experimental | Combination Product: CYP-006TKParticipants will receive CYP-006TK dressings |
| Group 2 - Standard of Care | No intervention | –Participants will continue to be treated as per local standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults at least 18 years of age up to 80 years of age, inclusive.
- Have a current diagnosis of diabetes mellitus (DM)
- With at least one non-healing cutaneous ulcer on the foot or the lower legs
- With ankle brachial index (ABI) ≥ 0.4 and/or toe pressure >30 mmHg on the limb with the study ulcer.
- Participant co-morbidities are adequately managed, and the participant has a life expectancy of at least 6 months as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
Key exclusion criteria (15 listed)
- Planned vascular surgery, angioplasty, thrombolysis or amputation of the affected limb in the next six months.
- Pregnant or breastfeeding.
- Active infection in the study ulcer.
- Any sign of osteomyelitis associated with the study ulcer.
- Study ulcer extends to bone or periosteum (ulcers that reach a ligament, joint capsule, fascia, or tendon are not excluded).
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 |
|---|---|---|
| CYP-006TKCYP-006TK is allogenic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs) or Cymerus™ MSCs, seeded onto a heptylamine plasma polymer-coated silicone dressing | Combination product | Group 1 - CYP-006TK |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 24 weeks
Incidence of changes from baseline in haematology, biochemistry, and urinalysis parameters.
Time frame: 24 weeks
Results will be summarised by individual and by treatment group using descriptive statistics.
9 secondary outcomes
Percentage of area change of study ulcer from baseline to weeks 12 and 24
Time frame: 12 and 24 weeks
Number of days to complete ulcer healing
Time frame: 12 and 24 weeks
Number of days to 50% ulcer healing
Time frame: 12 and 24 weeks
Percentage change in ulcer volume from baseline to weeks 12 and 24
Time frame: 12 and 24 weeks
Changes from baseline in ulcer pain assessed using a Numeric Rating Scale
Time frame: 12 and 24 weeks
Number clinic/home care visits across groups
Time frame: 12 and 24 weeks
Differences across groups on ulcer dressing products used
Time frame: 12 and 24 weeks
Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule
Time frame: 12 and 24 weeks
Duration of clinic/home care visits across groups
Time frame: 12 and 24 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 24 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Jolanta Airey, MD study director
Cynata Therapeutics Limited
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYP-006TK in people with Diabetic Foot Ulcer and Cutaneous Ulcer, run by Cynata Therapeutics Limited at 4 sites in Australia.
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 9 inclusion and 15 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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 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.
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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 24 Jan 2025.