Actively Recruiting
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
Led by The Metis Foundation · Updated on 2022-02-01
24
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 years or older able to provide informed consent
- Ulcer size between 1 and 300 cm2
- Undermining or tunneling less than 3 cm from wound margin
- Wound grossly free of necrotic and/or infected tissue
- Baseline pain score of at least 2 on the Visual Analog Scale (VAS)
You will not qualify if you...
- Known allergy to standard care, KeraStat4 Gel ingredients, or Morphine
- Wounds with heavy or high-volume exudate or necrotic tissue
- Clinical signs of infection or wound contamination
- Unable to complete VAS pain score or pain journal
- Pregnant or nursing
- Prisoners
- Any condition that investigator determines compromises safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
South Texas Aesthetic and Reconstructive Surgery
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
V
Victoria Diaz, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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