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Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

NCT05607979 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-10-08

No results posted yet for this study

Summary

This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Lavior Diabetic Wound Gel

Daily application of hydrogel treatment for 60 days.

DRUG

Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Daily application of hydrogel treatment for 60 days.

Sponsors & Collaborators

  • Lavior Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Sung-Ho Steve Bae, DPM · Baefoot Podiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-05-01
Completion
2024-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607979 on ClinicalTrials.gov