Recruiting

Cellular Products, Acellular Products, Matrix Products

Sponsor:

Sequence LifeScience, Inc.

Code:

NCT07665268

Conditions

Skin Ulcer

Pressure Ulcer (PU)

Pressure Ulcer of Skin

Pressure Sore

Chronic Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Activate™ Matrix + SOC

AmnioDefend™ FT Matrix + SOC

Palisade™ DM Matrix + SOC

Sentry™ SL Matrix + SOC

Shelter™ DM Matrix + SOC

Study Details

Brief 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.

Conditions

Skin Ulcer

Pressure Ulcer (PU)

Pressure Ulcer of Skin

Pressure Sore

Chronic Ulcer

Study ID

NCT07665268

Start date

Jan 28, 2026

Status verified date

Jun, 2026

Completion date

Jan 28, 2028

Anticipated

Primary completion date

Jan 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Activate™ Matrix + SOC

Three layers: amnion, intermediate layer, and chorion

experimental: AmnioDefend™ FT Matrix + SOC

Three layers: amnion, intermediate layer, and chorion

experimental: Palisade™ DM Matrix + SOC

Two layers: amnion and chorion

experimental: Sentry™ SL Matrix + SOC

One layer: amnion

experimental: Shelter™ DM Matrix + SOC

Two layers: amnion and chorion

Interventions

Activate™ 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.

AmnioDefend™ FT Matrix + SOC

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 + SOC

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 + SOC

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 + SOC

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.

Primary outcome measure

  • Between Arm Difference for Complete Closure [ Time Frame: 0-20 Weeks ]

Central Contacts and Locations

Central contacts

Bennett Sarver

1-833-865-6300info@serenagroups.com

Amy Allen

1-833-865-6300info@serenagroups.com

Locations

Amber Stormer

Recruiting

North Royalton, Ohio, United States, 44133

Contacts

Amber Stormer, Admin

440-652-8748astormer@encoreclinicalservices.com

More Information

Sponsor

Sequence LifeScience, Inc.

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Ulcer
  • Pressure
  • Pressure Ulcer
  • Pressure Sore
  • Skin Ulcer
  • Pressure Ulcer of Skin
  • Chronic Ulcer
  • Wound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequence LifeScience, Inc. on 2026-06-24.