Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers.
The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study is divided into two distinct phases:
The following analysis is concerned with the characteristics of materials that are employed for the purpose of the distribution of pressure. This will entail the meticulous analysis of the response exhibited by the materials, with the objective of ascertaining their true biomechanical behaviour in volunteers devoid of active ulcers.
The materials selected in the first part will be applied for the treatment of revascularised neuroischaemic ulcers. This will determine which of the materials is the most suitable for treating the lesion.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: IVAN JULIAN ROCHINA, PhD
- Número de telefone: +34 639687251
- E-mail: ivan.julian@uv.es
Locais de estudo
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Valencia
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Valencia, Valencia, Espanha
- Recrutamento
- Hospital Universitario y Politécnico La Fe
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Contato:
- IVAN JULIAN ROCHINA
- Número de telefone: +34639687251
- E-mail: ivan.julian@uv.es
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Aged between 55 and 75.
- Diagnosis of diabetes mellitus.
- Patients with an ankle-brachial index of >0.8 and <1.2.
- Signature of the informed consent form
Exclusion Criteria:
- Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
- Foot trauma within the last month.
- Inability to adhere to the full schedule of measurements required by the study.
- Participants who do not sign the informed consent form.
- Known contact dermatitis to any of the study materials
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: felt padding
The 5 mm and 10 mm felt pads are applied for 4 days.
|
The 5 mm felt pad is applied for 4 days and then removed.
After allowing the skin at least 48 hours to recover, the 10 mm felt pad is applied, also for 4 days.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Near-infrared perfusion index (NIR perfusion)
Prazo: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Thermography
Prazo: Baseline and 4 days
|
The images will be captured using the FLIR C8 thermal imaging camera.
The camera in question features a true thermal resolution of 320 × 240 pixels (76,800 measurement points) and MSX® technology, which combines visual and thermal details into a single image, thereby facilitating the detection of anatomical abnormalities.
Thermographic variables of interest included differences in absolute temperature values (maximum and mean temperature) within the region of interest corresponding to the offloading area.
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Baseline and 4 days
|
|
Peak pressure (Pmax)
Prazo: Baseline and 4 days
|
Peak pressure (Pmax) measured at the metatarsal head corresponding to the highest dynamic pressure. Plantar pressures were assessed using the EPS+R platform (Loran Engineering®, Bologna, Italy). The platform measures 50 × 70 × 4 mm, weighs 7 kg, and incorporates 2304 resistive sensors measuring 9 × 9 mm each. The pressure range is 50-350 kPa, with a maximum acquisition frequency of 100 Hz. Biomech® Studio 2019 software (LetSense Srl, Loran Engineering®) was used for data analysis. |
Baseline and 4 days
|
|
Tissue oxygen saturation (StO₂)
Prazo: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue hemoglobin index (THI)
Prazo: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue wáter index (TWI)
Prazo: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Tissue lipid index (TLI)
Prazo: Baseline and 4 days
|
Hyperspectral imaging was performed using the TIVITA® 2.0 camera (Diaspective Vision GmbH, Germany).
This non-contact, non-invasive device captures images across multiple wavelengths within the visible and near-infrared spectrum (500-1000 nm), enabling assessment of microcirculatory parameters up to a tissue depth of approximately 8 mm.
The device provides an image resolution of 640 × 480 pixels, with an acquisition time of 6.4 seconds.
Images were analyzed using TIVITA® Suite software by selecting a circular region of interest adjusted to the metatarsal head and offloading area under study.
|
Baseline and 4 days
|
|
Mean pressure (Pmean)
Prazo: Baseline and 4 days
|
Mean pressure (Pmean) measured at the metatarsal head corresponding to the highest dynamic pressure. Plantar pressures were assessed using the EPS+R platform (Loran Engineering®, Bologna, Italy). The platform measures 50 × 70 × 4 mm, weighs 7 kg, and incorporates 2304 resistive sensors measuring 9 × 9 mm each. The pressure range is 50-350 kPa, with a maximum acquisition frequency of 100 Hz. Biomech® Studio 2019 software (LetSense Srl, Loran Engineering®) was used for data analysis. |
Baseline and 4 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020-672-1
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