Wound of SkinPhase 4NCT05217160
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
A Phase 4 study testing KeraStat® Gel with Morphine application and KeraStat® Gel application in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin, Burns
- What is being tested?
- KeraStat® Gel with Morphine application and KeraStat® Gel application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2021to 31 May 2022
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 or older able to provide informed consent.
- 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
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- 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
- Pregnant or nursing
- Prisoner
- Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
South Texas Aesthetic and Reconstructive Surgery
San Antonio, Texas, 78229
Victoria Diaz, 210-569-1140, diaz@metisfoundationusa.org
About this study
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.
Read the detailed description
Chronic wounds pose a serious challenge to wound care professionals, as open and non-healing ulcers are often painful and difficult to treat. Patients are less compliant because of their pain and also run the risk of increased pain medication exposure in treating these wounds. A great deal of healthcare resources are dedicated to the treatment of non-healing open wounds. KeraStat® Gel offers a novel method for the topical delivery of Morphine to manage pain during the treatment of healing these problematic wounds.
Proof of concept work showed that a single treatment application of opioid-loaded keratin hydrogels produced extended analgesia that lasted up to two days in both sensitized and non-sensitized models of pain in rodents. This work then moved the proposed product into a porcine large animal study that showed topical morphine did not delay wound healing or re-epithelization and did not impact dermal thickness or Transforming Growth Factor Beta 1 (TGF1). Additionally, pharmacokinetics assessments showed that topical delivery of morphine to a burn wound resulted in no detectable morphine in animal serum.
KeraStat® Gel is a sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. Keratin is a structural, filamentous protein that, when hydrated, forms a hydrogel that provides coverage and maintains a moist environment for injured skin, similar to collagen and other extracellular matrix molecules used in existing products. Therefore, KeraStat® Gel is expected to behave in an equivalent manner to conventional biopolymer wound dressings. ISO 10993 biocompatibility studies and performance testing, both in vitro and in vivo, indicated that KeraStat® Gel is safe and biocompatible. Additionally, two clinical studies support the assertion that the product is non-sensitizing, non-irritating, and does not produce a humoral response. The current study is designed to provide pilot data to inform a power calculation to determine whether KeraStat® Gel plus Morphine reduces pain associated with dressing changes which may secondarily reduce daily pain and pain medication consumption.
This study is intended to evaluate the efficacy of KeraStat® Gel with Morphine in treating and/or minimizing the pain associated with chronic open wounds and subsequently replace or reduce the need for systemic analgesia.
Long-term impacts include improving tolerance to dressing changes resulting in better adherence to the treatment of painful open wounds, as well as giving providers an alternative to systemic narcotics which are dangerous, have many negative side effects, and are highly addictive. Data from this project will also support further studies in evaluating and assessing patients who have painful wounds and their chronic management.
- Conditions
- Wound of Skin, Burns
- Being tested
- KeraStat® Gel with Morphine application, KeraStat® Gel application
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraStat® Gel with Morphine applicationDrug
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 applicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| KeraStat® Gel with Morphine | Experimental | 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.
Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above. Receives: Drug: KeraStat® Gel with Morphine application |
| KeraStat® Gel | Active comparator | 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 5mL tubes.
Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above. Receives: Drug: KeraStat® Gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and Every 2 weeks for up to 12 weeks
Change in Adverse event assessment
Assessment of adverse events throughout the course of the subject treatment.
Measured: 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.
Measured: Day 0 and Every 2 weeks for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start11 May 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive either treatment with Kerastat or treatment with Kerastat with Morphine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217160
- Sponsor's protocol ID
- KeraStat
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
- ClinicalTrials.gov ID
- NCT05217160
- Acronym / sponsor ID
- KeraStat
- Conditions
- Wound of Skin, Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic wounds pose a serious challenge to wound care professionals, as open and non-healing ulcers are often painful and difficult to treat. Patients are less compliant because of their pain and also run the risk of increased pain medication exposure in treating these wounds. A great deal of healthcare resources are dedicated to the treatment of non-healing open wounds. KeraStat® Gel offers a novel method for the topical delivery of Morphine to manage pain during the treatment of healing these problematic wounds.
Proof of concept work showed that a single treatment application of opioid-loaded keratin hydrogels produced extended analgesia that lasted up to two days in both sensitized and non-sensitized models of pain in rodents. This work then moved the proposed product into a porcine large animal study that showed topical morphine did not delay wound healing or re-epithelization and did not impact dermal thickness or Transforming Growth Factor Beta 1 (TGF1). Additionally, pharmacokinetics assessments showed that topical delivery of morphine to a burn wound resulted in no detectable morphine in animal serum.
KeraStat® Gel is a sterile, non-implantable, water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. Keratin is a structural, filamentous protein that, when hydrated, forms a hydrogel that provides coverage and maintains a moist environment for injured skin, similar to collagen and other extracellular matrix molecules used in existing products. Therefore, KeraStat® Gel is expected to behave in an equivalent manner to conventional biopolymer wound dressings. ISO 10993 biocompatibility studies and performance testing, both in vitro and in vivo, indicated that KeraStat® Gel is safe and biocompatible. Additionally, two clinical studies support the assertion that the product is non-sensitizing, non-irritating, and does not produce a humoral response. The current study is designed to provide pilot data to inform a power calculation to determine whether KeraStat® Gel plus Morphine reduces pain associated with dressing changes which may secondarily reduce daily pain and pain medication consumption.
This study is intended to evaluate the efficacy of KeraStat® Gel with Morphine in treating and/or minimizing the pain associated with chronic open wounds and subsequently replace or reduce the need for systemic analgesia.
Long-term impacts include improving tolerance to dressing changes resulting in better adherence to the treatment of painful open wounds, as well as giving providers an alternative to systemic narcotics which are dangerous, have many negative side effects, and are highly addictive. Data from this project will also support further studies in evaluating and assessing patients who have painful wounds and their chronic management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either treatment with Kerastat or treatment with Kerastat with Morphine.
| Arm | Type | Receives |
|---|---|---|
| KeraStat® Gel with Morphine | Experimental | Drug: KeraStat® Gel with Morphine applicationAdministration 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. Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above. |
| KeraStat® Gel | Active comparator | Drug: KeraStat® Gel applicationAdministration 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 5mL tubes. Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects age 18 or older able to provide informed consent.
- 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
Key exclusion criteria (8 listed)
- 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
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeraStat® Gel with Morphine applicationAdministration 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. | Drug | KeraStat® Gel with Morphine |
| KeraStat® Gel applicationAdministration 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. | Drug | KeraStat® Gel |
Primary outcome
Change in Visual Analog Scale
Time frame: Day 0 and Every 2 weeks for up to 12 weeks
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.
Change in Adverse event assessment
Time frame: Day 0 and Every 2 weeks for up to 12 weeks
Assessment of adverse events throughout the course of the subject treatment.
1 secondary outcome
Change in Pressure Sore Quality of Life questionnaire
Time frame: Day 0 and Every 2 weeks for up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KeraStat® Gel with Morphine application and KeraStat® Gel application in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Diaz, RN (210-916-5760, Diaz@metisfoundationusa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (time frame: Day 0 and Every 2 weeks for up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.