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

> **NCT06319287** · PHASE2 · COMPLETED · sponsor: **Rion Inc.** · enrollment: 59 (actual)

## Conditions studied

- Diabetic Foot Ulcer

## Interventions

- **BIOLOGICAL:** PEP (Purified Exosome Product) / TISSEEL

## Key facts

- **NCT ID:** NCT06319287
- **Lead sponsor:** Rion Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-02-27
- **Primary completion:** 2025-04-23
- **Final completion:** 2025-11-01
- **Target enrollment:** 59 (ACTUAL)
- **Last updated:** 2026-01-20

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06319287

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06319287, "Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)". Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/clinical/NCT06319287. Licensed CC0.

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