2000 Participants NeededMy employer runs this trial

Matrix Products for Pressure Ulcers

(RESTORE Trial)

BS
AA
Overseen ByAmy Allen
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Sequence LifeScience, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TS

Thomas Serena, MD

Principal Investigator

Serena Group

Are You a Good Fit for This Trial?

This trial is for people with chronic, nonhealing pressure ulcers (bed sores) or similar skin wounds. Participants must have these types of hard-to-heal sores and meet basic health requirements set by the study team.

Inclusion Criteria

Potential subject must agree to attend the weekly study visits required by the protocol
Potential subject must be willing and able to participate in the informed consent process
I am 18 years old or older.
See 3 more

Exclusion Criteria

I have end stage kidney disease and need dialysis.
My main ulcer is not caused by pressure.
Potential subject is known to have a life expectancy of less than 3 months
See 14 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares several new wound healing products—Activate Matrix, AmnioDefend FT Matrix, Palisade DM Matrix, Sentry SL Matrix, Shelter DM Matrix—each used along with standard care, against standard care alone to see which helps heal stubborn pressure ulcers best.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Shelter™ DM Matrix + SOCExperimental Treatment1 Intervention
Group II: Sentry™ SL Matrix + SOCExperimental Treatment1 Intervention
Group III: Palisade™ DM Matrix + SOCExperimental Treatment1 Intervention
Group IV: AmnioDefend™ FT Matrix + SOCExperimental Treatment1 Intervention
Group V: Activate™ Matrix + SOCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sequence LifeScience, Inc.

Lead Sponsor

Serena Group

Collaborator

Trials
6
Recruited
790+