Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Completed · Phase 2/Phase 3

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT05607979

Run by

Lavior Pharma Inc.

People needed

75

Starts

2022-12-15

Expected to finish

2024-05-01

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Baefoot Podiatry — Miami, Florida, United States

Full record on ClinicalTrials.gov

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