Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Sex: All

Ages: 18 Years – N/A

Phase: PHASE2, PHASE3

Enrollment: 100

Sponsor: Lavior Pharma Inc.

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.

Eligibility Criteria

Inclusion Criteria:Foot Wound in the setting of Diabetes MellitusWritten informed consentMinimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)Exclusion Criteria:Age < 18 yearsNoncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial DiseaseMalignancy of the woundUse of any other hydrogels not being studied in this investigation within 1 month of being enrolledDry, uninfected, stable pressure ulcers of the heelDry, stable eschar in arterial woundsSimultaneous participation in competing clinical trialsPregnancy or Nursing mothers

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05607979). StuddyBuddy aggregates publicly available trial information.