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. (RESTORE)

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Ulcer; Pressure Ulcer of Skin; Chronic Ulcer; Pressure Sore; Pressure Ulcer (PU); Pressure Wound
• Intervention / Treatment: Other: Activate™ Matrix + SOC; Other: AmnioDefend™ FT Matrix + SOC; Other: Palisade™ DM Matrix + SOC; Other: Sentry™ SL Matrix + SOC; Other: Shelter™ DM Matrix + SOC

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bennett Sarver; Phone Number: 1-833-865-6300; Email: info@serenagroups.com
• Study Contact Backup: Name: Amy Allen; Phone Number: 1-833-865-6300; Email: info@serenagroups.com

Study Locations

• United States
  • Ohio
    • North Royalton, Ohio, United States, 44133
      • Recruiting
      • Amber Stormer
      • Contact: Amber Stormer, Admin; Phone Number: 440-652-8748; Email: astormer@encoreclinicalservices.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activate™ Matrix + SOC; Three layers: amnion, intermediate layer, and chorion	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.
Experimental: AmnioDefend™ FT Matrix + SOC; Three layers: amnion, intermediate layer, and chorion	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.
Experimental: Palisade™ DM Matrix + SOC; Two layers: amnion and chorion	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.
Experimental: Sentry™ SL Matrix + SOC; One layer: amnion	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.
Experimental: Shelter™ DM Matrix + SOC; Two layers: amnion and chorion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-20 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Closure	Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.	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.	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.	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.	0-20 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-20 Weeks
Compliance with Off-loading	To determine compliance with off-loading and the effect on wound closure.	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.	0-20 Weeks
Rate of Reoccurrence	Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.	0-20 Weeks

Collaborators and Investigators

• Sponsor: Sequence LifeScience, Inc.
• Collaborators: Serena Group
• Investigators: Principal Investigator: Thomas Serena, MD, Serena Group

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Estimated): January 28, 2028
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Wound; Pressure Ulcer; Ulcer; Skin Ulcer; Pressure; Pressure Sore; Chronic Ulcer; Pressure Ulcer of Skin
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Ulcer; Wounds and Injuries; Pressure Ulcer; Skin Ulcer
• Other Study ID Numbers: Pro00092936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No