Actively Recruiting
Pilot Study of KeraStat4 Gel with Morphine for Managing Pain in Non-Healing, Painful Open Wounds and Ulcers
Led by The Metis Foundation · Updated on 2022-02-01
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of KeraStat4 Gel combined with Morphine for managing pain in people who have painful, long-lasting open wounds or ulcers. These wounds are often difficult to treat and cause significant pain, which can lead to increased use of pain medications and challenges in wound care. The study focuses on whether applying this gel can reduce daily pain levels, pain during dressing changes, and the need for other pain medicines. Participants will receive either KeraStat4 Gel with Morphine or KeraStat4 Gel alone. The gel is applied topically to the wound area using 5 mL tubes covering about 300 cm2, approximately 1.5% of body surface area for an average adult. Dressing changes will be done every 1 to 3 days, with instructions provided for home use by participants or their caregivers. The treatment will be applied bi-weekly in a clinical setting and more frequently at home as directed. During the study, participants will have their pain levels assessed using a Visual Analog Scale and adverse events monitored every two weeks for up to 12 weeks. Quality of life related to pressure sores will also be measured regularly. The study will monitor safety and the impact of the gel on wound healing while tracking pain management, dressing adherence, and medication use, aiming to provide alternatives to systemic pain treatments.
CONDITIONS
Brief 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 age 18 or older able to provide informed consent
- Ulcer size between 1 and 300 cm2
- Undermining or tunneling less than 3 cm from wound margin
- Wounds grossly free of necrotic and/or infected tissue
- Baseline pain score of at least 2 on Visual Analog Scale (VAS)
You will not qualify if you...
- Known allergy to standard care, any ingredient in KeraStat4 Gel, or morphine
- Wounds with heavy or high-volume exudate or necrotic tissue
- Clinical signs of infection or contamination of the wound
- Inability to complete the VAS pain score in a pain journal
- Pregnant or nursing individuals
- Prisoners
- Any condition that the Investigator determines would compromise safety or prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive KeraStat® Gel with Morphine or KeraStat® Gel applied to their wounds. Dressings are changed every 1 to 3 days at home by participants or their caregivers, with bi-weekly in-person visits for assessment and application guidance.
Bi-weekly visits and dressing changes every 1 to 3 days at home
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
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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