Diabetic Neuropathic Ulcer Clinical Trial
Official title:
An Interventional, Multicenter, Single Arm, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-DFU on Wound Healing of Diabetic Neuropathic Ulcer (DFU)
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound surface area reduction of Diabetic Foot Ulcers) and safety (by monitoring adverse events) of two doses of the allogeneic investigational medicinal product "allo-APZ2-DFU" topically administered to the wound matrix of patients with diabetic neuropathic ulcer.
This is an interventional, single arm, phase I/IIa clinical trial to investigate the efficacy
and safety of allogeneic ABCB5-positive mesenchymal stem cells (MSCs) on wound healing in
patients with diabetic neuropathic ulcer. Allogeneic MSCs will be isolated ex vivo and will
be expanded in vitro. The Investigational medicinal product (IMP) containing the
ABCB5-positive MSCs will then be applied two times (at Visit 3 and six weeks later, at Visit
10) on the wound surface of DFU.
Patients are followed up for efficacy for a period of three months starting after the first
IMP application which allows to distinguish actual wound healing from transient wound
coverage.
The wound healing process will be documented by standardized photography. The wound size
reduction evaluation will start two weeks after the first IMP application. The quality of the
wound healing process will be assessed on the basis of formation of granulation tissue,
epithelialization and wound exudation.
Pain will be assessed using a numerical rating scale and quality of life will be investigated
with standardized and validated questionnaires. To assess long-term safety of allo-APZ2-DFU
three follow-up visits at Months 6, 9 and 12 after the first IMP application are included.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05729334 -
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
|
N/A |