Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety

Status Recruiting

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

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms