Ulcers de pernas venosas sem cicatrizes tratadas com atendimento padrão com ou sem BR-AC
Um estudo prospectivo, multicêntrico, randomizado e controlado de úlceras de pernas venosas não curativas tratadas com atendimento padrão com ou sem BR-AC
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.
This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care only in the treatment of venous leg ulcers. The eligibility criteria for this study will allow for enrollment of subjects with a VLU in the range of 2 cm^2 to 20 cm^2 in area. A lower size of 2 cm^2 was selected to exclude subjects who are likely to heal under compression therapy alone.
During the two-week run-in period, subjects who show a reduction in wound area predictive of achieving complete wound closure within 12 weeks under standardized care alone (i.e., compression therapy) will be excluded from the study. Eliminating these subjects will improve the estimated treatment effect. The criteria for duration, ≥ 4 weeks but ≤ 52 weeks, allows for the selection of those wounds that have demonstrated chronicity but may still have the potential to achieve wound closure.
The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for evaluating venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence, debridement, and compression therapy. Weekly subject visits will help monitor compliance in wound care and compression therapy, as well as to document when wound closureis achieved. The study will implement the use of an electronic imaging and measurement device (eKare inSight®) using a standardized protocol to ensure the measuring of the wound surface area is accurate, highly reproducible, and minimally variable.
There will also be a crossover treatment phase for those patients that were relegated to SOC only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.
A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up period will consist of a four-week follow-up with two visits at each two-week interval.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alabama
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Guntersville, Alabama, Estados Unidos, 35976
- Site 17
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California
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Castro Valley, California, Estados Unidos, 94546
- Site 2b
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Glendale, California, Estados Unidos, 91204
- Site 19b
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Oxnard, California, Estados Unidos, 93030
- Site 36
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Oxnard, California, Estados Unidos, 93036
- Site 37
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Palmdale, California, Estados Unidos, 93551
- Site 19
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San Francisco, California, Estados Unidos, 94115
- Site 02
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San Francisco, California, Estados Unidos, 94117
- Site 2a
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Sylmar, California, Estados Unidos, 91342
- Site 04
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Torrance, California, Estados Unidos, 90502
- Site 30
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Vista, California, Estados Unidos, 92081
- Site 01
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Florida
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Aventura, Florida, Estados Unidos, 33180
- Site 34
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Coral Gables, Florida, Estados Unidos, 33134
- Site 27
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Deerfield Beach, Florida, Estados Unidos, 33442
- Site 20
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Miami, Florida, Estados Unidos, 33126
- Site 35
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Miami, Florida, Estados Unidos, 33189
- Site 31
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Illinois
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O'Fallon, Illinois, Estados Unidos, 62269
- Site 06
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Site 18
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Missouri
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St Louis, Missouri, Estados Unidos, 63128
- Site 32
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New York
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Lake Success, New York, Estados Unidos, 11042
- Site 16
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Texas
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Corpus Christi, Texas, Estados Unidos, 78414
- Site 38
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Fort Worth, Texas, Estados Unidos, 76104
- Site 03
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Patient has signed the informed consent form.
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Male or female patient at least 18 years of age or older, as of the date of the screening visit.
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Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
- If the subject presents with > 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
- If the target ulcer is < 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.
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Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
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Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
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Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.
a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.
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Arterial supply adequacy confirmed by any one of the following:
- Great toe pressure ≥ 50 mm/Hg
- Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
- TcPO2 ≥ 40 mmHg from the foot
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Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.
Exclusion Criteria:
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
- Clinical evidence of ulcer bed infection, or infected hardware.
- Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
- Refusal or inability to tolerate compression therapy.
- Pregnant women.
- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
- Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol).
- Current therapy with systemic antibiotics.
- Current therapy with cytotoxic agents.
- Current therapy with chronic (> 10 days) oral corticosteroids.
- Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
- Currently on dialysis or planning to start dialysis.
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
- Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
- Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
- Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BR-AC plus Standard Care
All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as:
Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application. |
BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization. |
|
Comparador Ativo: Standard Care
All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as:
|
Standard Care is defined as:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone.
Prazo: over the 12-week treatment period
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Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization |
over the 12-week treatment period
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure
Prazo: at 12 weeks
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Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization |
at 12 weeks
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To compare differences between treatment groups in percent change in wound area (cm2)
Prazo: at 12 weeks
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Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization |
at 12 weeks
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To determine the total number of applications of BR-AC needed to achieve complete wound closure
Prazo: at 12 weeks
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Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization |
at 12 weeks
|
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To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone
Prazo: over an additional 12 weeks
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Time in days from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart |
over an additional 12 weeks
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants that acquire clinical signs and symptoms of infections post-randomization
Prazo: over 12-weeks post-randomization
|
Differences in clinical signs and symptoms of infection from Visit 2 through end of study between the treatment groups |
over 12-weeks post-randomization
|
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Proportion of subjects experiencing adverse events, by treatment group
Prazo: over the 17-week study period
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Spontaneously reported and elicited adverse events, coded in MedDRA |
over the 17-week study period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Bert Slade, MD, Independent
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Doenças de pele
- Úlcera de pele
- Varizes
- Úlcera de perna
- Doenças da Pele e do Tecido Conjuntivo
- Úlcera varicosa
- Insuficiência Venosa
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- BR-AC-VLU-101
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