Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers

Launched by THE METIS FOUNDATION · Jan 19, 2022

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ClinConnect Summary

This clinical trial is studying a product called KeraStat® Gel that contains morphine, which is being tested to help manage pain in people with chronic, non-healing open wounds or ulcers. The main goal is to see if this gel can effectively reduce pain levels experienced by participants, especially during wound dressing changes and overall daily pain. Researchers are looking for participants who are at least 18 years old, have open wounds of a certain size, and are experiencing a minimum level of pain.

If you or someone you know has a painful chronic wound and meets the eligibility criteria, you might consider participating in this study. Participants will be asked to track their pain levels and how much pain medication they use over the course of the trial. It’s important to note that individuals with certain medical conditions or allergies may not be able to join. This study is currently recruiting, and taking part could help improve pain management for others with similar wounds in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects age 18 or older able to provide informed consent.
• • 2. Ulcer size 1-300 cm2
• • 4. Undermining/tunneling \<3 cm from wound margin 5. Grossly free of necrotic and/or infected tissue 6. Baseline minimum of 2 on VAS pain scale
• Exclusion Criteria:
• Subjects who meet any of the following criteria will be excluded from the study:
• • 1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
• • 2. Wound has heavy or high-volume exudate or necrotic tissue
• • 3. Clinical signs of infection or contamination of the wound
• • 4. Subjects unable to complete the VAS pain score in pain journal
• • 5. Pregnant or nursing
• • 6. Prisoner
• • 7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study