- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07665268
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)
17. juni 2026 opdateret af: Sequence LifeScience, Inc.
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
2000
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bennett Sarver
- Telefonnummer: 1-833-865-6300
- E-mail: info@serenagroups.com
Undersøgelse Kontakt Backup
- Navn: Amy Allen
- Telefonnummer: 1-833-865-6300
- E-mail: info@serenagroups.com
Studiesteder
-
-
Ohio
-
North Royalton, Ohio, Forenede Stater, 44133
- Rekruttering
- Amber Stormer
-
Kontakt:
- Amber Stormer, Admin
- Telefonnummer: 440-652-8748
- E-mail: astormer@encoreclinicalservices.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Activate™ Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
|
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
|
|
Eksperimentel: AmnioDefend™ FT Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
|
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.
|
|
Eksperimentel: Palisade™ DM Matrix + SOC
Two layers: amnion and chorion
|
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.
|
|
Eksperimentel: Sentry™ SL Matrix + SOC
One layer: amnion
|
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.
|
|
Eksperimentel: Shelter™ DM Matrix + SOC
Two layers: amnion and chorion
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Between Arm Difference for Complete Closure
Tidsramme: 0-20 Weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Closure
Tidsramme: 0-20 Weeks
|
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
Tidsramme: 0-20 Weeks
|
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
Tidsramme: 0-20 Weeks
|
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
Tidsramme: 0-20 Weeks
|
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
|
0-20 Weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate Quality of Life
Tidsramme: 0-20 Weeks
|
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
Tidsramme: 0-20 Weeks
|
To determine compliance with off-loading and the effect on wound closure.
|
0-20 Weeks
|
|
Ulcers to Close in Patients over 65
Tidsramme: 0-20 Weeks
|
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
Tidsramme: 0-20 Weeks
|
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
|
0-20 Weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Serena, MD, Serena Group
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
28. januar 2026
Primær færdiggørelse (Anslået)
28. januar 2028
Studieafslutning (Anslået)
28. januar 2028
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00092936
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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