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New treatment option for Wound of Skin
Official title Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
ClinicalTrials.gov ID: NCT05217160
What this study is testing
What is KeraStat® Gel with Morphine application?
KeraStat® Gel with Morphine application is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for wound of skin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people age 18 or older able to provide informed consent.
- Ulcer size 1-300 cm2 4\. Undermining/tunneling \<3 cm from wound margin 5. Grossly free of necrotic and/or infected tissue 6. Baseline minimum of 2...
You likely can't join if
- people 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
- people unable to complete the VAS pain score in pain journal
- Pregnant or nursing
See the full eligibility criteria
- people age 18 or older able to provide informed consent.
- Ulcer size 1-300 cm2 4\. 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
- people 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.