Skin UlcerPhase 4RESTORENCT07665268
Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
A Phase 4 study testing Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC and Palisade™ DM Matrix + SOC in people with Skin Ulcer and Pressure Ulcer (PU), run by Sequence LifeScience, Inc. at 1 site in United States.
Trial summary
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin
- What is being tested?
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC and Palisade™ DM Matrix + SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to 28 Jan 2028
- 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
- The potential subject must be at least 18 years of age or older.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.
- The potential subject has adequate off-loading of the ulcer
Who cannot join
- The potential subject is known to have a life expectancy of < 3 months.
- The potential subject's target ulcer is not a pressure ulcer.
- The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- The target ulcer has undermining or tunneling.
- There is evidence of osteomyelitis complicating the target ulcer.
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- The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
- The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length × width is acceptable).
- The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- The potential subject has end stage renal disease requiring dialysis.
- The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- The potential subject has a malnutrition indicator score of <17 as measured on the Mini Nutritional Assessment.
- Known hemoglobin of < 8 g/dL as this is an indicator of poor wound healing.
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
Amber Stormer
North Royalton, Ohio, 44133
Amber Stormer, Admin, 440-652-8748, astormer@encoreclinicalservices.com
About this study
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
Read the detailed description
This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore, Chronic Ulcer, Pressure Wound
- Being tested
- Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC, Palisade™ DM Matrix + SOC, Sentry™ SL Matrix + SOC, Shelter™ DM Matrix + SOC
- Keywords
- Ulcer, Pressure, Pressure Ulcer, Pressure Sore, Skin Ulcer, Pressure Ulcer of Skin, Chronic Ulcer, Wound
- Medical subject headings
- Skin Ulcer, Pressure Ulcer, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activate™ Matrix + SOCOther
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
AmnioDefend™ FT Matrix + SOCOther
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Palisade™ DM Matrix + SOCOther
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Sentry™ SL Matrix + SOCOther
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Shelter™ DM Matrix + SOCOther
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Activate™ Matrix + SOC | Experimental | Three layers: amnion, intermediate layer, and chorion Receives: Other: Activate™ Matrix + SOC |
| AmnioDefend™ FT Matrix + SOC | Experimental | Three layers: amnion, intermediate layer, and chorion Receives: Other: AmnioDefend™ FT Matrix + SOC |
| Palisade™ DM Matrix + SOC | Experimental | Two layers: amnion and chorion Receives: Other: Palisade™ DM Matrix + SOC |
| Sentry™ SL Matrix + SOC | Experimental | One layer: amnion Receives: Other: Sentry™ SL Matrix + SOC |
| Shelter™ DM Matrix + SOC | Experimental | Two layers: amnion and chorion Receives: Other: Shelter™ DM Matrix + SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between Arm Difference for Complete Closure
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
Measured: 0-20 Weeks
Secondary outcomes (4)
Time to Closure
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
Measured: 0-20 Weeks
Percentage Area Reduction
Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
Measured: 0-20 Weeks
Pain Scale Reduction
Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.
Measured: 0-20 Weeks
Adverse Events
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
Measured: 0-20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start28 Jan 2026
- Primary completion28 Jan 2028 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin UlcerStudies 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
- Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequence LifeScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, Serena Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665268
- Sponsor's protocol ID
- Pro00092936
- Acronym
- RESTORE
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: A Multicenter, Prospective, Modified Platform Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers.
- ClinicalTrials.gov ID
- NCT07665268
- Acronym / sponsor ID
- RESTORE / Pro00092936
- Conditions
- Skin Ulcer, Pressure Ulcer (PU), Pressure Ulcer of Skin, Pressure Sore, Chronic Ulcer, Pressure Wound
- Keywords
- Ulcer, Pressure, Pressure Ulcer, Pressure Sore, Skin Ulcer, Pressure Ulcer of Skin, Chronic Ulcer, Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sequence LifeScience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Serena Group
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 28 Jan 2028 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 24 Jun 2026 (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.
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
Detailed description
This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.
| Arm | Type | Receives |
|---|---|---|
| Activate™ Matrix + SOC | Experimental | Other: Activate™ Matrix + SOCThree layers: amnion, intermediate layer, and chorion |
| AmnioDefend™ FT Matrix + SOC | Experimental | Other: AmnioDefend™ FT Matrix + SOCThree layers: amnion, intermediate layer, and chorion |
| Palisade™ DM Matrix + SOC | Experimental | Other: Palisade™ DM Matrix + SOCTwo layers: amnion and chorion |
| Sentry™ SL Matrix + SOC | Experimental | Other: Sentry™ SL Matrix + SOCOne layer: amnion |
| Shelter™ DM Matrix + SOC | Experimental | Other: Shelter™ DM Matrix + SOCTwo layers: amnion and chorion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The potential subject must be at least 18 years of age or older.
- The potential subject must agree to attend the weekly study visits required by the protocol.
- The potential subject must be willing and able to participate in the informed consent process.
- The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
- At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device.
Key exclusion criteria (16 listed)
- The potential subject is known to have a life expectancy of < 3 months.
- The potential subject's target ulcer is not a pressure ulcer.
- The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- The target ulcer exposes tendon or bone.
- The target ulcer has undermining or tunneling.
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 |
|---|---|---|
| Activate™ Matrix + SOCParticipants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Other | Activate™ Matrix + SOC |
| AmnioDefend™ FT Matrix + SOCParticipants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Other | AmnioDefend™ FT Matrix + SOC |
| Palisade™ DM Matrix + SOCParticipants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Other | Palisade™ DM Matrix + SOC |
| Sentry™ SL Matrix + SOCParticipants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Other | Sentry™ SL Matrix + SOC |
| Shelter™ DM Matrix + SOCParticipants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. | Other | Shelter™ DM Matrix + SOC |
Primary outcome
Between Arm Difference for Complete Closure
Time frame: 0-20 Weeks
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
4 secondary outcomes
Time to Closure
Time frame: 0-20 Weeks
Percentage Area Reduction
Time frame: 0-20 Weeks
Pain Scale Reduction
Time frame: 0-20 Weeks
Adverse Events
Time frame: 0-20 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 24 Jun 2026.
- 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.
Thomas Serena, MD principal investigator
Serena Group
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 Activate™ Matrix + SOC, AmnioDefend™ FT Matrix + SOC and Palisade™ DM Matrix + SOC in people with Skin Ulcer and Pressure Ulcer (PU), run by Sequence LifeScience, Inc. 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 6 inclusion and 16 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 24 Jun 2026. 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 Bennett Sarver (1-833-865-6300, info@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between Arm Difference for Complete Closure (time frame: 0-20 Weeks). 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 24 Jun 2026.