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NCT05217160 · ClinicalTrials.gov registry record · Phase 4
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
A Phase 4 study of Burns and Wound of Skin, sponsored by The Metis Foundation.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05217160: Recruiting Phase 4 study of Burns and Wound of Skin, sponsored by The Metis Foundation.
NCT05217160 is a Phase 4 study of Burns and Wound of Skin that is actively recruiting participants, run by The Metis Foundation. The registered enrollment target is 24 participants, below the 83-participant average among 36 other Burns trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05217160, a Phase 4 study of Burns and Wound of Skin, is actively recruiting participants, sponsored by The Metis Foundation.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG KeraStat® Gel with Morphine application
- DRUG KeraStat® Gel application
Study Locations (1)
Texas
- South Texas Aesthetic and Reconstructive Surgery - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 4 |
What NCT05217160 shows while recruiting
NCT05217160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 83-participant average among 36 other Burns trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Burns appearing as the primary indexed condition, and to 2 interventions - of which KeraStat® Gel with Morphine application is the first listed.
NCT05217160 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05217160 about?
NCT05217160 is a clinical study titled "Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers". 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...
What is the current status of trial NCT05217160?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2021-05-11. Estimated completion is 2022-05-31.
What conditions does trial NCT05217160 study?
This clinical trial studies the following conditions: Burns, Wound of Skin.
What interventions are being tested in trial NCT05217160?
The interventions under investigation include: KeraStat® Gel with Morphine application (DRUG), KeraStat® Gel application (DRUG).
Who is sponsoring clinical trial NCT05217160?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05217160 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Burns
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05217160's enrollment target sits among peer trials
24 20th of 36 higher than 17 of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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