Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Parallel-group, Standard of Care-controlled Clinical Trial to Evaluate the Use of AMNIOEXCEL® in the Management of Chronic Diabetic Foot Ulcers
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Potential study candidates will be Screened for Inclusion and Exclusion criteria after providing informed consent. Candidates will have their wound cleansed and debrided (if necessary), photographed and measured. Blood will be drawn for laboratory analyses. Patients will return two weeks later for assessment.
Upon return, per the original protocol, patient would have been randomized at <20% closure; per Amendment 1, if the wound has closed <30% in area during the 2 week Screening Period and all other eligibility criteria are met, the patient will be randomized (1:1) to receive either AMNIOEXCEL® with Standard of Care (SOC) or SOC alone.
All patients enrolled in this study will receive SOC. For the purposes of this study, Standard of Care (SOC) includes debridement of necrotic/non-viable tissue, moist wound dressings, off-loading (where appropriate, DH Walker only) and infection surveillance and management. For those randomized to receive AMNIOEXCEL®, in addition to SOC, the tissue will be applied after the wound has been debrided and hemostasis achieved. The wound will then be dressed with a non-adherent dressing (e.g. Adaptic) and covered with a moisture retentive dressing.
The patient will return once weekly for wound care, photographs and ulcer measurement. At each visit, the wound will be assessed and AMNIOEXCEL® reapplied as appropriate, based upon physician judgment. All patients complete their participation at Week 6.
This is an open label study and no attempt will be made to blind subjects or Investigators to randomization allocation.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85015
- Associated Foot and Ankle Specialists, LLC
-
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California
-
Castro Valley, California, Estados Unidos, 94546
- Center for Clinical Research, Inc.
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Stockton, California, Estados Unidos, 95204
- Pacific Wound Center
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- First Coast Cardiovascular Institute
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North Miami Beach, Florida, Estados Unidos, 33169
- Barry University Clinical Research
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-
Massachusetts
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Plymouth, Massachusetts, Estados Unidos, 02360
- Beth Israel Deaconess Hospital - Plymouth
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Goldsboro, North Carolina, Estados Unidos, 27533
- Wayne Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- an ambulatory person at least 18 years of age at the time of informed consent.
- type 1 or type 2 diabetes mellitus.
- glycosylated hemoglobin (HbA1c) of ≤12%
at least one wound that is/has:
- Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
- duration of at least 1 month,
- no clinical signs of infection or osteomyelitis,
- between 1cm2 and 25cm2 in area,
- per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
- located on the foot, distal to malleoli.
- adequate circulation to the affected extremity
- serum creatinine of <3.0mg/dl.
Exclusion Criteria:
- participated in another clinical trial within 30 days prior to consent,
- Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
- receiving radiation or chemotherapy of any kind,
- known or suspected malignancy of current ulcer,
- pregnant or breast feeding,
- an active malignant disease,
- receiving hemo- or peritoneal dialysis,
- sickle cell anemia or Raynaud's syndrome,
- diagnosis of autoimmune connective tissue disease,
- received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
- exposed bone, tendon or joint capsule in the study ulcer,
- currently receiving antibiotics (for any reason), or
- taking medications considered to be immune system modulators.
Plano de estudo
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 |
|---|---|
|
Comparador Ativo: AMNIOEXCEL
Human Amniotic Membrane Allograft
|
Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
|
Comparador Ativo: Standard of Care, Diabetic Foot Ulcers
Advanced wound care dressings and offloading of wound.
|
Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment
Prazo: 8 weeks
|
8 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Time to complete wound closure of the target ulcer
Prazo: 8 weeks
|
8 weeks
|
|
|
Rate of wound closure
Prazo: 8 Weeks
|
8 Weeks
|
|
|
Incidence, severity and type of adverse events
Prazo: 8 Weeks
|
This outcome measure represents a composite of collected adverse event data.
|
8 Weeks
|
|
Changes in Quality of Life assessment
Prazo: 8 Weeks
|
8 Weeks
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Doenças Vasculares
- Doenças cardiovasculares
- Diabetes Mellitus
- Úlceras do Pé Diabético
- Complicações do Diabetes
- Angiopatias Diabéticas
- Ferimento
- Doenças do Sistema Endócrino
- Doenças de pele
- Úlcera de perna
- Úlcera
- Úlcera de pele
- Doenças dos pés
- Úlcera do pé
- Pé diabético
- Neuropatias diabéticas
- Saúde dos pés
- Úlceras do pé de Grau 1 ou 2 de Wagner
- AMNIOEXCEL
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DS2014.01.01
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