KeraStat® Gel with Morphine for Painful Open Wounds

This study is testing KeraStat® Gel with Morphine to see if it can reduce pain in people with non-healing, painful open wounds and ulcers. Researchers want to see if applying this gel directly to the wound can lower daily pain levels, reduce pain during dressing changes, and decrease the need for other pain medications. You might be able to join if you are 18 or older, have a painful open wound between 1 and 300 square centimeters, and have a minimum pain level of 2 on a pain scale. The study will measure changes in your pain levels and any side effects over 12 weeks to see how well the gel works.

Study design
This is an interventional study planning to enroll 24 participants. It compares KeraStat® Gel with Morphine to KeraStat® Gel alone.
What's involved
You would have KeraStat® Gel applied every two weeks for up to 12 weeks. You would also apply the gel at home every 1-3 days and change dressings.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels and adverse events will be assessed for up to 12 weeks.

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NCT05217160

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
The Metis Foundation
~24 participants
Updated 2022-02-01 on ClinicalTrials.gov
What's tested:KeraStat® Gel with Morphine applicationKeraStat® Gel application

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Visual Analog Scale
Measured over Day 0 and Every 2 weeks for up to 12 weeks
+1 more outcome measured
Wound of Skin
Burns
1 sites across 1 states
Texas1

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  • Change in Visual Analog ScaleDay 0 and Every 2 weeks for up to 12 weeks

    This unidimensional measure is composed of a line, usually 10 centimeters in length, anchored by two verbal descriptors representing the symptom extremes ("no pain" and "worst imaginable pain") and 6 facial expression anchors.

  • Change in Adverse event assessmentDay 0 and Every 2 weeks for up to 12 weeks

    Assessment of adverse events throughout the course of the subject treatment.