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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 de julho de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

147

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • California
      • San Diego, California, Estados Unidos, 92104
        • Recrutamento
        • North Park Podiatry
        • Contato:
        • Investigador principal:
          • Trent Brookshier
    • Florida
      • Coral Gables, Florida, Estados Unidos, 33134
        • Recrutamento
        • Solutions Medical Research
        • Contato:
        • Investigador principal:
          • Francisco Jose Oliva
      • Miami, Florida, Estados Unidos, 33176
        • Recrutamento
        • Nova Medical Services - Research Division LLC
        • Contato:
        • Investigador principal:
          • Sandor Romero
      • Miami, Florida, Estados Unidos, 33135
        • Recrutamento
        • NAR Medical and Research
        • Contato:
        • Investigador principal:
          • Julio Arronte
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Recrutamento
        • Indiana University Health Methodist Hospital
        • Contato:
        • Investigador principal:
          • Mithun Sinha
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63128
        • Recrutamento
        • St. Louis Foot and Ankle, LLC
        • Contato:
        • Investigador principal:
          • Raymond Abdo
    • Texas
      • Houston, Texas, Estados Unidos, 77054
        • Recrutamento
        • HOPE Vascular and Podiatry
        • Contato:
        • Investigador principal:
          • Brian Lepow

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.)
Dispositivo: 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.
Experimental: 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.)
Dispositivo: 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,
Outros nomes:
  • IP 2: Microlyte®
Sem intervenção: 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.)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Wound Reduction
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Wound Percent Area Reduction
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Capsicure, LLC

Colaboradores

BioLab Holdings

Investigadores

  • Diretor de estudo: Windy Cole, DPM, Capsicure, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de junho de 2026

Conclusão Primária (Estimado)

20 de dezembro de 2026

Conclusão do estudo (Estimado)

20 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CAMPR-II RWE

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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