Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06319287 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
A Phase 2 study of Diabetic Foot Ulcer, sponsored by Rion.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT06319287: Completed Phase 2 study of Diabetic Foot Ulcer, sponsored by Rion.
NCT06319287 is a Phase 2 study of Diabetic Foot Ulcer that has completed, run by Rion. The registered enrollment target is 59 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06319287, a Phase 2 study of Diabetic Foot Ulcer, has completed, sponsored by Rion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study 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)
Primary Outcome
Complete wound closure (wound healing) by 12 weeks (efficacy; landmark analysis)
Conditions Studied
Interventions
- BIOLOGICAL PEP (Purified Exosome Product) / TISSEEL
Study Locations (1)
Ohio
- Professional Education & Research Institute (PERI) - Blue Ash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2025-11-01 |
| Phase | Phase 2 |
What the finished NCT06319287 record still lists
NCT06319287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which PEP (Purified Exosome Product) / TISSEEL is the first listed.
NCT06319287 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06319287 about?
NCT06319287 is a clinical study titled "Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)". 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)
What is the current status of trial NCT06319287?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2024-02-27. Estimated completion is 2025-11-01.
What conditions does trial NCT06319287 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT06319287?
The interventions under investigation include: PEP (Purified Exosome Product) / TISSEEL (BIOLOGICAL).
Who is sponsoring clinical trial NCT06319287?
This trial is sponsored by Rion, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06319287 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06319287's enrollment target sits among peer trials
59 48th of 67 higher than 20 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
RECRUITING · Phase 2
-
Smart Boot Use to Measure Offloading Adherence
RECRUITING · Phase 2
-
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
RECRUITING · Phase 2
-
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
COMPLETED · Phase 2
-
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
COMPLETED · Phase 2
-
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI