NCT06825884: EVDFUUJCTC

Use of Extracellular Vesicles (EV) for Diabetic Foot Ulcers

Active, enrolled Phase 1 Last updated 16 April 2025

What this trial tests

Phase 1 trial testing Extracellular micro vesicles (EV) in Diabetic Foot Ulcer in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2024

Primary endpoint
31 December 2027

31 January 2028

Quick facts

Lead sponsor	University of Jordan
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 December 2024
Primary completion	31 December 2027
Estimated completion	31 January 2028
Sites	1 location across Jordan

Drugs / interventions tested

• Extracellular micro vesicles (EV) — full drug profile →

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

University of Jordan

Who can join

Adults 30 to 75, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 the result of diabetic foot ulcers. Compromised chronic cutaneous ulcer healing may result from cytokines, growth factor deficits, and insufficient angiogenesis process.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biological and Bioinspired Vesicles for Wound Healing: Insights, Advances and Challenges.
   Zhao Y, Zhang T, Zhao G, Lu J, et al · · 2025 · cited 2× · PMID 40620685 · DOI 10.2147/ijn.s522067
2. Tuning mechanical softness as a design principle in drug delivery: A biomechanical perspective.
   Qi K, Zhang S, Bi X, Zhang Z, et al · · 2026 · cited 1× · PMID 41909730 · DOI 10.1016/j.apsb.2025.11.037
3. Biological Nanoparticles for Enhancing Chronic Wound Regeneration.
   Zotikov D, Ponomareva N, Brezgin S, Kostyusheva A, et al · · 2025 · cited 1× · PMID 41148851 · DOI 10.3390/cells14201637
4. Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
   Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378
5. Hydrogel-extracellular vesicle engineering delivery system: a promising therapeutic strategy for wound healing.
   Gao F, Hu Z, Xu H, Yu Y, et al · · 2026 · PMID 41814281 · DOI 10.1186/s12951-026-04236-1
6. Human umbilical cord mesenchymal stromal cells derivatives in treating diabetic foot ulcers: a phase I/II safety and efficacy trial.
   Jafar H, Almousa R, Alhawari H, Shahin D, et al · · 2025 · PMID 41287013 · DOI 10.1186/s13287-025-04736-1