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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine. In gathering data from subjects who have baseline pain from their chronically open wounds, the investigators can then evaluate the capacity of KeraStat® Gel plus Morphine in reducing the subjects daily pain levels, pain associated with dressing changes, and pain medication consumption.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Metis Foundation
• Treatments: Morphine

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