Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lavior Medical, Inc.

Criteria

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