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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - CYP-006TK | Experimental | Participants will receive CYP-006TK dressings |
|
| Group 2 - Standard of Care | No Intervention | Participants will continue to be treated as per local standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYP-006TK | Combination Product | CYP-006TK is allogenic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs) or Cymerusâ„¢ MSCs, seeded onto a heptylamine plasma polymer-coated silicone dressing |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of area change of study ulcer from baseline to weeks 12 and 24 | 12 and 24 weeks | |
| Number of days to complete ulcer healing | 12 and 24 weeks | |
| Number of days to 50% ulcer healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jolanta Airey, MD | Cynata Therapeutics Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Adelaide Local Health Network | Adelaide | South Australia | 5000 | Australia | ||
| Fiona Stanley Hospital |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 12 and 24 weeks |
| Percentage change in ulcer volume from baseline to weeks 12 and 24 | 12 and 24 weeks |
| Changes from baseline in ulcer pain assessed using a Numeric Rating Scale | 12 and 24 weeks |
| Number clinic/home care visits across groups | 12 and 24 weeks |
| Differences across groups on ulcer dressing products used | 12 and 24 weeks |
| Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule | 12 and 24 weeks |
| Duration of clinic/home care visits across groups | 12 and 24 weeks |
| Perth |
| Western Australia |
| Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| Sir Charles Gairdner Hospital | Perth | Western Australia | Australia |
| D007871 |
| Leg Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |