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Biological

PEP-TISSEEL+SOC for Foot Ulcer

Phase 2

Recruiting

Research Sponsored by Rion Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test if using a topical treatment called PEP-TISSEEL is safe and effective for treating diabetic foot ulcers.

Who is the study for?

This trial is for individuals with diabetic foot ulcers. Specific criteria aren't provided, but typically participants would need to have a confirmed diagnosis of DFU and be in stable health otherwise.Check my eligibility

What is being tested?

The study is testing PEP-TISSEEL, applied topically on diabetic foot ulcers. It's designed to see if this treatment is safe and works well (efficacy) compared to other treatments or placebos.See study design

What are the potential side effects?

While specific side effects are not listed, topical treatments like PEP-TISSEEL could potentially cause skin irritation, allergic reactions, or infection at the application site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety

Wound Closure

Secondary outcome measures

Percent Area Reduction of Wound at 12 Weeks

Other outcome measures

Semmes-Weinstein Score

Visual Analogue Scale (VAS) for Pain over 12 weeks

Wound-Q Scale

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PEP-TISSEEL+SOCActive Control1 Intervention

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

Group II: Standard of CarePlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Rion Inc.Lead Sponsor

1 Previous Clinical Trials

8 Total Patients Enrolled

Professional Education and Research InstituteOTHER

13 Previous Clinical Trials

1,028 Total Patients Enrolled

12 Trials studying Foot Ulcer

999 Patients Enrolled for Foot Ulcer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study still ongoing?

"Absolutely. As indicated in clinicaltrials.gov, this particular research study is currently seeking candidates. The trial was originally uploaded on February 27th, 2024, and the most recent update transpired on March 13th, 2024. With one site involved in the recruitment process, a total of 40 participants are being sought for inclusion in this trial."

Answered by AI

Has the combination of PEP-TISSEEL with standard of care been granted approval by the FDA?

"Given that this is a Phase 2 trial, our team at Power has rated the safety of PEP-TISSEEL+SOC as a 2 on the scale. This indicates some existing safety data but no evidence to support efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319287.

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