Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers

General Information

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). 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.
Clinical trials phase Phase 1
Start date (estimated) 2022-01-04
End date (estimated) 2023-12-31
Clinical feature
Label diabetic foot
Link http://www.ebi.ac.uk/efo/EFO_1001459
Description A diabetic foot is a foot that exhibits any pathology that results directly from diabetes mellitus or any long-term (or "chronic") complication of diabetes mellitus. Presence of several characteristic diabetic foot pathologies such as infection, diabetic foot ulcer and neuropathic osteoarthropathy is called diabetic foot syndrome.

Administrative Information

NCT number NCT05165628
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05165628
Other study identifiers
Name CYP-DFU-P1-01
Source weblink https://clinicaltrials.gov/ct2/show/NCT05165628
Public contact
Email clinical@cynata.com
Public email clinical@cynata.com
First name Cynata Therapeutics Limited
Last name Cynata Therapeutics Limited
Phone +61 3 7067 6940
Country
Australia
Sponsors Cynata Therapeutics Limited

Cells

Recruitment

Recruitment Status Recruiting
Estimated number of participants 30