What side effects are associated with this type of intervention?

Common treatments for foot ulcers that involve topical applications to promote wound healing and tissue regeneration include various dressings, growth factors, and tissue-engineered products. Known side effects of these treatments can include local skin irritation, allergic reactions, and infection at the application site. Some advanced therapies, such as those involving growth factors or tissue-engineered products, may also carry risks of delayed wound healing or adverse immune responses. It is important to monitor for these side effects and consult with a healthcare provider to manage any complications.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers that focus on promoting wound healing and tissue regeneration. These include topical agents like becaplermin gel (Regranex), which contains a recombinant human platelet-derived growth factor to stimulate tissue repair. Additionally, advanced wound care products such as collagen-based dressings, hydrogels, and skin substitutes like Apligraf and Dermagraft have been approved to enhance the healing process. These treatments aim to create an optimal environment for wound healing, similar to the approach being studied with PEP-TISSEEL.

What other types of research exist?

One promising alternative to PEP-TISSEEL for diabetic foot ulcers is NorLeu(3)-angiotensin (1-7) (NorLeu(3)-A(1-7)). This analog of angiotensin 1-7 has demonstrated high effectiveness in accelerating wound closure through mechanisms such as progenitor proliferation, vascularization, collagen deposition, and re-epithelialization.

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Biological

PEP-TISSEEL for Diabetic Foot Ulcers

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

Summary

This trial is testing a special glue-like substance called PEP-TISSEEL combined with usual treatments on patients with non-healing diabetic foot ulcers. The goal is to see if this combination helps wounds heal better by sticking tissues together and promoting faster healing.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety

Wound Closure

Secondary study objectives

Percent Area Reduction of Wound at 12 Weeks

Other study objectives

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for foot ulcers, such as the topical application of agents like PEP-TISSEEL, work by promoting wound healing and tissue regeneration. These treatments typically provide a scaffold for new tissue growth, deliver growth factors that stimulate cell proliferation, and create a barrier against infections. This is particularly important for foot ulcer patients as it accelerates the healing process, reduces the risk of infections, and improves the overall prognosis by enhancing the body's natural ability to repair damaged tissues.

Dressings and topical agents for arterial leg ulcers.