What side effects are associated with this type of intervention?

Common treatments for foot ulcers that promote wound healing through hydration and antimicrobial properties, such as hydrogels, may cause side effects including local skin irritation, redness, and allergic reactions. Some patients might experience a burning or stinging sensation upon application. Additionally, improper use or prolonged application can lead to maceration of the surrounding healthy skin. It is important to monitor for signs of infection or adverse reactions and consult a healthcare provider if any severe side effects occur.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers that promote wound healing through hydration and antimicrobial properties. Notable examples include hydrogels like Intrasite Gel and Purilon Gel, which maintain a moist wound environment conducive to healing. Additionally, antimicrobial dressings such as silver-impregnated dressings (e.g., Aquacel Ag) have been approved to reduce bacterial load and prevent infection. These treatments aim to enhance the wound healing process by providing necessary moisture and antimicrobial action, similar to the properties of Lavior Diabetic Wound Gel.

What other types of research exist?

Promising novel alternatives to Lavior Diabetic Wound Gel for foot ulcer patients include: 1) Advanced hydrogels with enhanced antimicrobial properties, such as those incorporating silver nanoparticles or honey. 2) Platelet-rich plasma (PRP) therapy, which uses concentrated platelets to promote healing. 3) Low-level laser therapy (LLLT), which has shown potential in improving wound healing and reducing symptoms. 4) Medical ozone therapy, which has demonstrated benefits in small studies for wound healing. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Hydrogel

Wound Gels for Diabetic Foot Ulcers (RENEW Trial)

Phase 2 & 3

Waitlist Available

Led By Sung-Ho Steve Bae, DPM

Research Sponsored by Lavior Pharma 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 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special gel called Lavior Diabetic Wound Gel to see if it heals wounds in diabetic patients as well as other similar gels. The gel is applied to the wound to keep it moist and help it heal faster. The study will be conducted in multiple locations and will start in an outpatient setting.

Who is the study for?

This trial is for adults with diabetes who have a foot wound at least the size of a small coin. They must be able to follow the study's procedures and visit schedule. People can't join if they're under 18, pregnant, nursing, have gangrene or certain artery diseases, cancer in the wound area, or are using other gels not studied here.

What is being tested?

The study compares two treatments for diabetic foot ulcers: Lavior Diabetic Wound Gel and Smith & Nephew Solosite Gel Hydrogel Wound Dressing. It aims to see if one gel helps wounds heal better than the other when used as part of regular outpatient care.

What are the potential side effects?

Potential side effects may include skin irritation around the wound site from either gel. Since these are topical treatments, systemic side effects are less common but could still occur depending on individual reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Endpoint

Secondary study objectives

Change in Pain Scores over time (60 days)

Injury wounds

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: TRIAL INTERVENTIONActive Control1 Intervention

Trial intervention is wound treatment with Lavior Diabetic Wound Gel.

Group II: CONTROL THERAPYActive Control1 Intervention

Control therapy is defined as Smith \& Nephew Solosite Gel Hydrogel Wound Dressing, according to actual guidelines or local clinical standards. Standard therapy is defined as the currently accepted and widely used treatment for the respective wound type, based on the results of past research. Therapy options for standard wound care are treatments that experts agree to be appropriate, accepted, and widely used.

Do I qualify?Apply below to find out

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 hydrogels and antimicrobial gels, work by promoting wound healing through hydration and infection control. Hydrogels maintain a moist environment, which is essential for cell migration and tissue repair, while antimicrobial agents reduce bacterial load, preventing infections that can delay healing. These mechanisms are crucial for foot ulcer patients as they enhance the healing process and improve clinical outcomes.