Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Last updated: October 7, 2024
Sponsor: Lavior Pharma Inc.
Overall Status: Completed

Phase

2/3

Condition

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Lavior Diabetic Wound Gel

Clinical Study ID

NCT05607979
RENEW-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Foot Wound in the setting of Diabetes Mellitus

  • Written informed consent

  • Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Noncompliance with study procedures, visit schedule or follow up Gangrene and/oruntreatable Peripheral Arterial Disease

  • Malignancy of the wound

  • Use of any other hydrogels not being studied in this investigation within 1 month ofbeing enrolled

  • Dry, uninfected, stable pressure ulcers of the heel

  • Dry, stable eschar in arterial wounds

  • Simultaneous participation in competing clinical trials

  • Pregnancy or Nursing mothers

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Smith & Nephew Solosite Gel Hydrogel Wound Dressing
Phase: 2/3
Study Start date:
December 15, 2022
Estimated Completion Date:
May 01, 2024

Connect with a study center

  • Baefoot Podiatry

    Miami, Florida 33138
    United States

    Site Not Available

  • Wagonor Hospital

    Wagoner, Oklahoma 74467
    United States

    Site Not Available

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