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

Diabetic Foot Ulcer Clinical Trial

Official title:
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)

Clinical Trial Summary

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)

Clinical Trial 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 40 subjects (20 subjects PEP-TISSEEL + SOC and 20 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® - 3M Cavilon® (may be used on the borders prior to placing the Tegaderm®) - Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)); and - Offloaded with an offloading Controlled Ankle Movement (CAM) Boot (FootDefender (Miami, FL) or Total Contact Cast (TCC)) Treatment for the Standard of Care (SOC) only arm is: - Fibracol - Mepitel dressing followed by Tegaderm® (or equivalent) - 3M Cavilon® (may be used on the borders prior to placing the Tegaderm® or equivalent) - Padded 3-layer secondary outer layer dressing (Profore (Smith and Nephew (Memphis, TN)) or equivalent); and - Offloaded with an offloading CAM Boot (FootDefender (Miami, FL) or TCC) Enrolled subjects will be randomized in a 1:1 ratio with 20 subjects receiving 2 vials PEP delivered in 10 mL TISSEEL plus SOC and the other 20 subjects receiving SOC only. Before randomization, subjects must complete a two (2) week run-in period (Screening) in which they will be evaluated for inclusion and exclusion criteria and will receive standard of care treatment with required off-loading CAM Boot (FootDefender, Miami FL) or TCC. The Investigator will choose and document the appropriate type of off-loading modality based on their clinical judgement and the subject's diabetic foot ulcer off-loading requirements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06319287
Study type Interventional
Source Rion Inc.
Contact Shariq Khan, M.S.
Phone 847-702-4063
Email khan@riontx.com
Status Recruiting
Phase Phase 2
Start date February 27, 2024
Completion date July 12, 2025
View Details
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