Pilot Study of KeraStat Gel with Morphine for Treating Painful, Non-Healing Open Wounds and Ulcers

What this Trial Is About

This research aims to evaluate the use of KeraStat4 Gel combined with Morphine for managing pain in people who have painful, long-lasting open wounds or ulcers. These wounds are often difficult to treat and cause significant pain, which can lead to increased use of pain medications and challenges in wound care. The study focuses on whether applying this gel can reduce daily pain levels, pain during dressing changes, and the need for other pain medicines. Participants will receive either KeraStat4 Gel with Morphine or KeraStat4 Gel alone. The gel is applied topically to the wound area using 5 mL tubes covering about 300 cm2, approximately 1.5% of body surface area for an average adult. Dressing changes will be done every 1 to 3 days, with instructions provided for home use by participants or their caregivers. The treatment will be applied bi-weekly in a clinical setting and more frequently at home as directed. During the study, participants will have their pain levels assessed using a Visual Analog Scale and adverse events monitored every two weeks for up to 12 weeks. Quality of life related to pressure sores will also be measured regularly. The study will monitor safety and the impact of the gel on wound healing while tracking pain management, dressing adherence, and medication use, aiming to provide alternatives to systemic pain treatments.

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