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

NCT05165628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Cynata Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Jolanta Airey, MD · Cynata Therapeutics Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2024-09-24
Completion
2024-09-24

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05165628 on ClinicalTrials.gov