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Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers (BIORESCUE)

28. September 2026 aktualisiert von: BioLab Holdings

A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers

The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products.

Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • The potential subject must be at least 18 years of age or older.
  • The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
  • If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study.
  • The potential subject must consent to using the prescribed offloading method for the duration of the study.
  • 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 participated in the BIOCAMP trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.

Exclusion Criteria:

  • The potential subject is known to have a life expectancy of < 6 months.
  • The potential subject's target ulcer is not secondary to diabetes.
  • The target ulcer is infected or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
  • 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 is taking hydroxyurea.
  • The potential subject has applied topical steroids to the ulcer surface within one month of TV-1.
  • The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
  • The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of TV-1.
  • The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
  • 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 has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
  • The potential subject did not participate in the BIOCAMP trial.
  • The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm.
  • The potential subject participated in the BIOCAMP trial and achieved complete closure.
  • The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Tri-Membrane Wrap™ DFU

Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Sonstiges: Tri-Membrane Wrap™ DFU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap™ DFU

Membrane Wrap™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap™ DFU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap-Lite™ DFU

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap-Lite™ DFU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap-Hydro™ DFU

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap-Hydro™ DFU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Tri-Membrane Wrap™ VLU

Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Sonstiges: Tri-Membrane Wrap™ VLU

Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap™ VLU

Membrane Wrap™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap™ VLU

Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap-Lite™ VLU

Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap-Lite™ VLU

Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sonstiges: Membrane Wrap-Hydro™ VLU

Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Sonstiges: Membrane Wrap-Hydro™ VLU

Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Wound Closure
Zeitfenster: 1-12 Weeks

The percentage of target ulcers achieving complete wound closure in 12 weeks.
1-12 Weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Closure
Zeitfenster: 1-12 weeks

Time to closure for the target ulcer.
1-12 weeks
Percentage Area Reduction
Zeitfenster: 1-12 weeks

Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
1-12 weeks
Adverse Events
Zeitfenster: 1-12 Weeks

The number of product- or procedure- related adverse events.
1-12 Weeks
Determine improvement in Quality of Life
Zeitfenster: 1-12 weeks

To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."
1-12 weeks
Determine improvement in Quality of Life
Zeitfenster: 1-12 weeks

To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Wound Quality of Life (wQOL) questionnaire. Scores on a scare from "Not at all" to "Very much."
1-12 weeks
Pain in patients who present with VAS greater than 4
Zeitfenster: 1-12 Weeks

To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain
1-12 Weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

BioLab Holdings

Mitarbeiter

Serena Group

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Januar 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

16. Januar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Januar 2026

Zuerst gepostet (Tatsächlich)

23. Januar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. Februar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RescueX

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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