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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.

NCT07665268 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-06-24

No results posted yet for this study

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
  • Pressure Wound

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Sequence LifeScience, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Serena, MD · Serena Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2028-01-28
Completion
2028-01-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07665268 on ClinicalTrials.gov