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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 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.

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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.

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

FieldValue
Enrollment Target 24 participants
Start Date 2021-05-11
Est. Completion 2022-05-31
Phase Phase 4

Sponsor

The Metis Foundation

8 total trials

What the Registry Record Tells You About NCT05217160

The ClinicalTrials.gov registry entry for NCT05217160 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 36 other Burns trials with a reported enrollment target (71% lower). The listed sponsor is The Metis Foundation, which has 8 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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