Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds (RENEW)

Recruiting
18 years or above
All
Phase 2/3
100 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetic Foot Ulcer
  • Age: 18 years or above
  • Gender: All

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 Criteria:

  • Age < 18 years
  • Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease
  • Malignancy of the wound
  • Use of any other hydrogels not being studied in this investigation within 1 month of being 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

Updated on 07 Nov 2022. Study ID: RENEW-01

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