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

NCT05217160 | Recruiting Phase 4 FDA Drug

• 1 other identifier: KeraStat
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analog Scale

  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.

  Day 0 and Every 2 weeks for up to 12 weeks

• Change in Adverse event assessment

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

  Day 0 and Every 2 weeks for up to 12 weeks

Secondary Outcomes (1)

• Change in Pressure Sore Quality of Life questionnaire

  Day 0 and Every 2 weeks for up to 12 weeks

Study Arms (2)

KeraStat® Gel with Morphine

EXPERIMENTAL

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. Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.

Drug: KeraStat® Gel with Morphine application

KeraStat® Gel

ACTIVE COMPARATOR

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 5mL tubes. Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.

Drug: KeraStat® Gel application

Interventions

KeraStat® Gel with Morphine application DRUG

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.

KeraStat® Gel with Morphine

KeraStat® Gel application DRUG

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.

KeraStat® Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects age 18 or older able to provide informed consent.
• Ulcer size 1-300 cm2
• \. 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

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
• Wound has heavy or high-volume exudate or necrotic tissue
• Clinical signs of infection or contamination of the wound
• Subjects unable to complete the VAS pain score in pain journal
• Pregnant or nursing
• Prisoner
• Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

Sponsors & Collaborators

• The Metis Foundation: lead

Study Sites (1)

South Texas Aesthetic and Reconstructive Surgery

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Victoria Diaz, RN

CONTACT

210-916-5760; Diaz@metisfoundationusa.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, care givers and the investigators will be blinded to which treatment group the participants are randomized to receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive either treatment with Kerastat or treatment with Kerastat with Morphine.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 1, 2022
• Study Start: May 11, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)