NCT05165628

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

A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cynata Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcer
• Cutaneous Ulcer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CYP-006TK	CYP-006TK is allogenic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs) or Cymerus™ MSCs, seeded onto a heptylamine plasma polymer-coated silicone dressing

Timeline

• Start date: 2022-01-04
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2021-12-21
• Last updated: 2025-01-24

Locations

4 sites across 1 country: Australia