Topical Morphine Gel for Pain Relief in Chronic Wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.