Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

NCT06319287 ↗

Phase 2 Completed 59 enrolled Rion Inc. Professional Education and Research Institute · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

Timeline

Start: 2024-02-27
Primary completion: 2025-04-23
Completion: 2025-11-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Purified Exosome Product	Unknown	150 mg	Topical
Comparator	Fibrinogen Concentrate Human	Protein / enzyme biologic	10 ml	Topical

Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

Summary

Timeline

Drugs

Indications