Topical Morphine Gel for Pain Relief in Chronic Wounds
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
This study is testing if a morphine gel can help people with painful chronic wounds feel less pain and need less other pain medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Metis Foundation Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05217160 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of KeraStat® Gel, which contains Morphine, in managing pain associated with chronic, non-healing wounds and ulcers. Participants with painful open wounds will be assessed for pain reduction after applying the gel, focusing on daily pain levels, pain during dressing changes, and overall pain medication usage. The study aims to provide insights into a novel topical delivery method that could improve patient compliance and reduce reliance on systemic pain medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic, painful open wounds measuring between 1-300 cm².
Not a fit: Patients with known allergies to Morphine or KeraStat® Gel, or those with infected or heavily exudative wounds, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain for patients suffering from chronic wounds, improving their quality of life.
How similar studies have performed: Previous studies have shown promise in using topical morphine for pain management in wound care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects age 18 or older able to provide informed consent. 2. 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 Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine 2. Wound has heavy or high-volume exudate or necrotic tissue 3. Clinical signs of infection or contamination of the wound 4. Subjects unable to complete the VAS pain score in pain journal 5. Pregnant or nursing 6. Prisoner 7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Where this trial is running
San Antonio, Texas
- South Texas Aesthetic and Reconstructive Surgery — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Victoria Diaz, RN
- Email: Diaz@metisfoundationusa.org
- Phone: 210-916-5760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.