A Phase 4 interventional study of Activate™ Matrix + SOC and AmnioDefend™ FT Matrix + SOC in Skin Ulcer, Pressure Ulcer (PU) and Pressure Ulcer of Skin, sponsored by Sequence LifeScience, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Sequence LifeScience, Inc. · Phase 4, Interventional, and Treatment
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.
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
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Sequence LifeScience, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Pressure Ulcer, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Skin Ulcer. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three layers: amnion, intermediate layer, and chorion
Other: Activate™ Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
Other: AmnioDefend™ FT Matrix + SOC
Two layers: amnion and chorion
Other: Palisade™ DM Matrix + SOC
One layer: amnion
Other: Sentry™ SL Matrix + SOC
Two layers: amnion and chorion
Other: Shelter™ DM Matrix + SOC
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
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.
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.
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.
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.
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.
Time frame: 0-20 Weeks
Time to Closure
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-20 Weeks
Evaluate Quality of Life
Evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC only using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, 12, 16, and 20.
Time frame: 0-20 Weeks
Compliance with Off-loading
To determine compliance with off-loading and the effect on wound closure.
Time frame: 0-20 Weeks
Ulcers to Close in Patients over 65
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
Time frame: 0-20 Weeks
Rate of Reoccurrence
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
Time frame: 0-20 Weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
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Sequence LifeScience, Inc.