NCT06319287

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

A Phase 2a Multi-Center, Prospective, Randomized Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects With Diabetic Foot Ulcers (DFU)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Rion Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The objective of this multi-center, prospective, randomized controlled study is to evaluate the safety and efficacy of PEP-TISSEEL+ Standard of Care (SOC) compared to SOC only treatment in up to 60 subjects (30 subjects PEP-TISSEEL + SOC and 30 subjects SOC only), specifically for the treatment of their non-healing DFU. Treatment for the PEP-TISSEEL+SOC arm is: * PEP-TISSEEL * Mepitel dressing followed by Tegaderm® (Mepilex can be used if subjects are allergic to Tegaderm) * 3M Cavilon® (may be used on the borders prior to placing the Tegaderm or Mepilex) * Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)); and * Offloaded with an offloading Controlled Ankle Movement (CAM) Boot (Foot Defender (Miami, FL) or Total Contact Cast (TCC)) * Use of an alternate offloading device (e.g., Charcot Restraint Orthotic Walker (CROW) boot, custom shoe, etc.) may be approved on a case-by-case basis Treatment for the Standard of Care (SOC) only arm is: * Fibracol * Mepitel dressing followed by Tegaderm (Mepilex can be used if subjects are allergic to Tegaderm * 3M Cavilon (may be used on the borders prior to placing the Tegaderm or Mepilex) * Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)) or equivalent); and * Offloaded with an offloading CAM Boot (Foot Defender (Miami, FL) or TCC) * Use of an alternate offloading device (e.g., Charcot Restraint Orthotic Walker (CROW) boot, custom shoe, etc.) may be approved on a case-by-case basis

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	PEP (Purified Exosome Product) / TISSEEL	PEP Drug Product is a lyophilized powder contained within a 10R glass vial. PEP Drug Product is a lyophilized powder derived from apheresed platelets in plasma. The powder cake weighs approximately 75 mg per vial. This protocol will evaluate 2 vials of PEP Drug Product delivered in 10 mL TISSEEL fibrin sealant (15mg/mL PEP-TISSEEL) for 12 weeks. TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-04-23
• Completion: 2025-11-01
• First posted: 2024-03-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study