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

NCT05217160 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-01

No results posted yet for this 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

  • Wound of Skin
  • Burns

Interventions

DRUG

KeraStat® Gel with Morphine application

Administration and application of KeraStat® Gel with Morphine (Bi-Weekly): KeraStat® Gel with Morphine will be formulated by mixing liquid Morphine 25mg/mL into 5mg of KeraStat, this will be individually packaged in 5mL tubes at a concentration of 5mg/mL. Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel with Morphine (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel with Morphine in 5mL tubes.

DRUG

KeraStat® Gel application

Administration and application of KeraStat® Gel (Bi-Weekly): Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel in 5mL tubes.

Sponsors & Collaborators

  • The Metis Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217160 on ClinicalTrials.gov