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.

Part of paid clinical trials in North Royalton, Ohio.

Sponsor
Sequence LifeScience, Inc.
Study ID
NCT07665268
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Ulcer
  • Pressure Sore
  • Pressure Ulcer (PU)
  • Pressure Ulcer of Skin
  • Pressure Wound
  • Skin Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Activate™ Matrix + SOC — OTHER
    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 — OTHER
    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 — OTHER
    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 — OTHER
    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 — OTHER
    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 Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
Jun 2026
Primary completion
Jan 28, 2028
Completion
Jan 28, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amber StormerNorth RoyaltonOhio44133
Amber Stormer, Admin
[email protected]
440-652-8748

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Amber Stormer· North Royalton, OH

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