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CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs (CAMPR-II)

13 июля 2026 г. обновлено: Capsicure, LLC

A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs

CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hardto-heal DFUs and VLUs Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Study type Interventional comparative study Study product • IP 1: Membrane Wrap - Hydro™ • IP2: Microlyte® Matrix CSM matched cohort Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression. Prospective patient population Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Control population Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs Retrospective data to be extracted retrospectively from the US Wound Registry: Demographic information Geographic location Number of wounds Frequency and number of wound care appointments Treatments received Number of infections Amputations Hospitalization Time to complete wound closure PROMs (if available) Study purpose To gather prospective real-world evidence (RWE) in both diabetic foot ulcers and venous leg ulcers increasing the understanding of treatment performance in everyday clinical settings, capturing insights from a more diverse patient population than traditional clinical trials. This information is CAMPR-II Version 1.1 15 April 2026 7 vital for evaluating the effectiveness of innovative wound care strategies in practical, real-life scenarios Primary objective To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting complete wound closure compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care.

Тип исследования

Интервенционный

Регистрация (Оцененный)

147

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Marissa Docter, RN, BSN, MD
  • Номер телефона: 512-571-2966
  • Электронная почта: mdocter@capsicure.com

Места учебы

  • Соединенные Штаты
    • California
      • San Diego, California, Соединенные Штаты, 92104
        • Рекрутинг
        • North Park Podiatry
        • Контакт:
          • Marbella Lara
          • Номер телефона: 619-283-2097
          • Электронная почта: marbella.npp1@gmail.com
        • Главный следователь:
          • Trent Brookshier
    • Florida
      • Coral Gables, Florida, Соединенные Штаты, 33134
        • Рекрутинг
        • Solutions Medical Research
        • Контакт:
        • Главный следователь:
          • Francisco Jose Oliva
      • Miami, Florida, Соединенные Штаты, 33176
        • Рекрутинг
        • Nova Medical Services - Research Division LLC
        • Контакт:
        • Главный следователь:
          • Sandor Romero
      • Miami, Florida, Соединенные Штаты, 33135
        • Рекрутинг
        • NAR Medical and Research
        • Контакт:
        • Главный следователь:
          • Julio Arronte
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • Рекрутинг
        • Indiana University Health Methodist Hospital
        • Контакт:
          • Bryce Hockman
          • Номер телефона: 317-278-2715
          • Электронная почта: bbhockma@iu.edu
        • Главный следователь:
          • Mithun Sinha
    • Missouri
      • St Louis, Missouri, Соединенные Штаты, 63128
        • Рекрутинг
        • St. Louis Foot and Ankle, LLC
        • Контакт:
        • Главный следователь:
          • Raymond Abdo
    • Texas
      • Houston, Texas, Соединенные Штаты, 77054
        • Рекрутинг
        • HOPE Vascular and Podiatry
        • Контакт:
          • Jeena RoshanRaj
          • Номер телефона: 346-541-6421
          • Электронная почта: jroshanraj@hcic.io
        • Главный следователь:
          • Brian Lepow

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. Male or female 18 years of age and older

  2. If a female is not currently pregnant or breastfeeding nor plans to become pregnant during the study and is either not of childbearing potential (defined as: postmenopausal [defined as amenorrhea for at least 1 year and serum follicle stimulating hormone (FSH) level >40 IU/L], or surgically sterile [bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation at least 6 months prior to IP administration]), or is practicing one or more of the following medically acceptable methods of birth control throughout the study.

    1. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's usual menstrual cycle period) before Screening/Randomization Visit and must follow that product's package insert instructions including additional protection at times when hormonal contraceptive doses might be missed.
    2. Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening/Randomization Visit. Abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.
    3. Intrauterine device
    4. Vasectomized Partner (for at least 6 months)
    5. Double-barrier method (condoms and clerical cap with spermicidal jellies or cream or condoms and diaphragm with spermicidal jellies or cream or condoms and contraceptive foam).
  3. Negative pregnancy test for all subjects of childbearing potential
  4. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration.
  5. No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
  6. Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2
  7. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
  8. Subject is able and willing to follow the protocol requirements
  9. Subject has signed informed consent.

Exclusion Criteria:

  1. Inability to adhere to the study protocol or study visit schedule
  2. Pregnancy
  3. Child-bearing potential without appropriate contraception
  4. Lactation
  5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
  6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
  7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
  8. Known contraindications to the use of either IP1 or IP2
  9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: IP1: Membrane Wrap - Hydro
The study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)
Устройство: IP 1: Membrane Wrap - Hydro
IP 1: Membrane Wrap - Hydro is a saline-hydrated allogeneic dual-layer amniotic membrane product that meets the criteria for regulation as a human cell, tissue, or cellular or tissue-based product (HCT/P) solely under section 361 of the Public Health Service (PHS) Act and 21 CFR part 1271. The amnion allograft is screened, processed, labeled, and distributed in a manner that prevents transmission of disease and is an allograft derived from donated human birth tissue. Membrane Wrap - Hydro amniotic membrane processing includes cleaning, rinsing, applying sterile mesh, folding to create a dual layer, drying then cutting, followed by hydration with sodium chloride solution 0.9%" and sterilization using irradiation. Membrane Wrap - Hydro™ is intended to serve "as a supportive barrier and provides protective coverage from the surrounding environment to acute and chronic wounds. Membrane Wrap-Hydro may be applied from the onset of the wound and for the duration of the wound.
Экспериментальный: IP2: Microlyte®
This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)
Устройство: Microlyte®
IP 2: Microlyte® is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/in2. It absorbs wound fluid and forms a soft matrix that conforms to the wound surface and maintains a moist, wound-healing environment. The matrix contains silver only to prevent or minimize microbial growth within the matrix. Microlyte® Matrix is cleared by the U.S. Food and Drug Administration (FDA) under 510(k) [K153756] as a Class II device for the management of partial- and full-thickness wounds, including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, surgical and traumatic wounds, and first- and second-degree burns and may be used over debrided and grafted partial-thickness wounds. It is fully synthetic and cleared as an antimicrobial barrier. The product is regulated under 21 CFR 878.4020 (dressing, wound,
Другие имена:
  • IP 2: Microlyte®
Без вмешательства: Standard of Care
This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Wound Reduction
Временное ограничение: 12 Weeks
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound reduction compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care. Thus, the incidence of index ulcers obtaining complete wound reduction by 12 weeks will be collected.
12 Weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Wound Percent Area Reduction
Временное ограничение: Week 4, 8, and 12
To demonstrate real world utilization and utility of two novel amniotic tissue grafts to support a variety of meaningful clinical outcomes in an at-risk patient population this study will collect wound percent area reduction at 4, 8, 12 weeks, change from baseline in quality of life, based on changes in index wound quality of life Wound-Q, and subject pain scores.
Week 4, 8, and 12

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Capsicure, LLC

Соавторы

BioLab Holdings

Следователи

  • Директор по исследованиям: Windy Cole, DPM, Capsicure, LLC

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 июня 2026 г.

Первичное завершение (Оцененный)

20 декабря 2026 г.

Завершение исследования (Оцененный)

20 декабря 2026 г.

Даты регистрации исследования

Первый отправленный

8 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

13 июля 2026 г.

Первый опубликованный (Действительный)

14 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

13 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CAMPR-II RWE

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Да

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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