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)
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 4
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Bennett Sarver
- Numero di telefono: 1-833-865-6300
- Email: info@serenagroups.com
Backup dei contatti dello studio
- Nome: Amy Allen
- Numero di telefono: 1-833-865-6300
- Email: info@serenagroups.com
Luoghi di studio
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Ohio
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North Royalton, Ohio, Stati Uniti, 44133
- Reclutamento
- Amber Stormer
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Contatto:
- Amber Stormer, Admin
- Numero di telefono: 440-652-8748
- Email: astormer@encoreclinicalservices.com
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: Activate™ Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
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Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
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Sperimentale: AmnioDefend™ FT Matrix + SOC
Three layers: amnion, intermediate layer, and chorion
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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.
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|
Sperimentale: Palisade™ DM Matrix + SOC
Two layers: amnion and chorion
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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.
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Sperimentale: Sentry™ SL Matrix + SOC
One layer: amnion
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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.
|
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Sperimentale: Shelter™ DM Matrix + SOC
Two layers: amnion and chorion
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Between Arm Difference for Complete Closure
Lasso di tempo: 0-20 Weeks
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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.
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0-20 Weeks
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to Closure
Lasso di tempo: 0-20 Weeks
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Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
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0-20 Weeks
|
|
Percentage Area Reduction
Lasso di tempo: 0-20 Weeks
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Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
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0-20 Weeks
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Pain Scale Reduction
Lasso di tempo: 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.
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0-20 Weeks
|
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Adverse Events
Lasso di tempo: 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
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluate Quality of Life
Lasso di tempo: 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.
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0-20 Weeks
|
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Compliance with Off-loading
Lasso di tempo: 0-20 Weeks
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To determine compliance with off-loading and the effect on wound closure.
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0-20 Weeks
|
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Ulcers to Close in Patients over 65
Lasso di tempo: 0-20 Weeks
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To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
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0-20 Weeks
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Rate of Reoccurrence
Lasso di tempo: 0-20 Weeks
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Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
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0-20 Weeks
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Thomas Serena, MD, Serena Group
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Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- Pro00092936
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