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)	2024-09-30
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
Which differentiated cell type is used	Label mesenchymal stem cell Link http://purl.obolibrary.org/obo/CL_0000134 Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.
Recruitment
Recruitment Status	Active, not recruiting
Estimated number of participants	30