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

Recruiting Phase 4 Interventional Study
Wound of Skin Burns
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
The Metis Foundation · Other
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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, pa…
Trial Locations
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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 …
Contacts

Victoria Diaz, RN

210-916-5760

Diaz@metisfoundationusa.org

CONTACT