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Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers

ConditionsWound of SkinBurns
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Metis Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects age 18 or older able to provide informed consent.

Ulcer size 1-300 cm2

Disqualifiers

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

Subjects unable to complete the VAS pain score in pain journal

Trial design

Design model

Parallel

Treatments tested in this trial

  • KeraStat® Gel with Morphine application

    Drug

    Administration and application of KeraStat® Gel with Morphine (Bi-Weekly): KeraStat® Gel with Morphine will be formulated by mixing liquid Morphine 25mg/mL into 5mg of KeraStat, this will be individually packaged in 5mL tubes at a concentration of 5mg/mL. Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel with Morphine (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel with Morphine in 5mL tubes.

  • KeraStat® Gel application

    Drug

    Administration and application of KeraStat® Gel (Bi-Weekly): Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel in 5mL tubes.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: KeraStat® Gel with MorphineExperimental treatment 1 intervention
Group B: KeraStat® GelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Visual Analog Scale

This unidimensional measure is composed of a line, usually 10 centimeters in length, anchored by two verbal descriptors representing the symptom extremes ("no pain" and "worst imaginable pain") and 6 facial expression anchors.

Time frame
Day 0 and Every 2 weeks for up to 12 weeks
2

Change in Adverse event assessment

Assessment of adverse events throughout the course of the subject treatment.

Time frame
Day 0 and Every 2 weeks for up to 12 weeks

Secondary outcomes

1

Change in Pressure Sore Quality of Life questionnaire

Standardized method to assess wound specific symptoms and functional outcomes for quantifying the benefits of associated interventions. The questionnaire is composed of 11 questions with 4 answer boxes for each question, the subject is asked to check one of the four boxes to evaluate the wound. The boxes are labeled No bother at all, A little bother, A lot of bother, and I had this problem but not because of my pressure sores.

Time frame
Day 0 and Every 2 weeks for up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Metis Foundation

Lead sponsor

Source ClinicalTrials.gov
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