NCT06825884

Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Jordan · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes related lower leg amputations are anticipated to the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.

Detailed description

Diabetes Mellitus is a common chronic medical condition that requires complex care strategies. Treatment includes methods to reduce glycemic burden and maintain glycemic control in the patient to prevent symptoms of hyperglycemia and reduce microvascular complications. In the case of patients with diabetes mellitus, wound healing, skin re- epithelization and skin integrity restoration are compromised, leading to chronic cutaneous ulcers such as diabetic foot ulcers. As much as 15% of all diabetic patients manifest diabetic foot ulcers. Moreover, 84% of all diabetes-related lower leg amputations are anticipated to be the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may be ascribed to cytokines, growth factor deficits, and insufficient angiogenesis process. Wound healing is a process that begins as a reaction to skin injury, re-epithelization is a crucial phase of the wound healing, and it is impelled by keratinocytes migration and proliferation. Cell migration and proliferation are initiated and regulated by growth factors and cytokines that are released from the wounded epithelium. Restoration of skin integrity in the case of chronic cutaneous ulcers in patients with diabetes mellitus is compromised. Autologous human platelet granules, such as human platelet lysate (hPL) and extracellular micro vesicles (EV), represent a promising source of bioactive substances and have shown to be effective both in vitro and in vivo in wound healing studies. Prior studies supported the use of platelet rich plasma and extracellular micro vesicles in healing chronic lower extremity wounds and the treatment of diabetic foot ulcers. The investigators are proposing this work for the use of bioactive substance: Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care. This is a clinical study in chronic DFU stage A2 and A3 as per the university of Texas DFU classification (Appendix I), corresponding to Wegner classification III; IV.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	Extracellular micro vesicles (EV)	Extracellular micro vesicles (EV) as direct perilesional injection into the diabetic chronic foot ulcers (DFU) which have not healed after using standard of care.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-31
• Completion: 2028-01-31
• First posted: 2025-02-13
• Last updated: 2025-04-16

Locations

1 site across 1 country: Jordan