Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Metis Foundation
About this trial
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.
Eligibility criteria
Qualifiers
Subjects age 18 or older able to provide informed consent.
Ulcer size 1-300 cm2
Disqualifiers
Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
Wound has heavy or high-volume exudate or necrotic tissue
Clinical signs of infection or contamination of the wound
Subjects unable to complete the VAS pain score in pain journal
Trial design
Treatments tested in this trial
- KeraStat® Gel with Morphine application
- KeraStat® Gel application
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov