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Hydrogel

Wound Gels for Diabetic Foot Ulcers (RENEW Trial)

Phase 2 & 3
Recruiting
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
Foot Wound in the setting of Diabetes Mellitus
Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

RENEW Trial Summary

This trial compares healing rates of Lavior Diabetic Wound Gel to other hydrogels in diabetic patients. Outpatient monitoring & follow-up included.

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.Check my eligibility
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.See study design
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.

RENEW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a foot wound and diabetes.
Select...
You need to have a wound that is at least 0.7 x 0.7 cm in size, which is about the size of a small coin.

RENEW Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint
Secondary outcome measures
Change in Pain Scores over time (60 days)
Injury wounds
Injury wounds
+3 more

RENEW 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.

Find a Location

Who is running the clinical trial?

Lavior Pharma Inc.Lead Sponsor
Sung-Ho Steve Bae, DPMPrincipal InvestigatorBaefoot Podiatry
Todd Hassenstein, DPMPrincipal InvestigatorOK Limb Salvage Center

Frequently Asked Questions

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

Is enrollment still possible for participants in this experiment?

"That is correct, the information on clinicaltrials.gov currently states that this trial is looking for participants. According to the website, the trial was posted on 11/1/2022 and was last updated on 11/3/2022. They are recruiting 100 patients from 1 location."

Answered by AI
~6 spots leftby May 2024