Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's response to any tissue injury is to deliver platelets, which play an instrumental role in the normal healing process by secreting growth factors and attracting stem cells-critical components of the healing cascade.
Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new options for wound healing. The efficacy of the treatment has been proven in surgical applications, in the treatment of severe burns and in transplantation of cells and tissues.
Local application of a solution of plasma enriched in platelets derived from the patient's blood intends to trigger the healing process in non-responsive chronic wound, increase the wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it utilizes the body's natural healing processes to jump-start wound healing. Plasma which contains very valuable growth factors is separated from other blood components utilizing a point of care technology based on density gradient centrifugation. The platelet rich plasma is harvested and then activated by a mixture of human thrombin and calcium chloride for initiating the healing cascade followed by PRP injection directly into the ulcer/wound periphery or spread over a wound in the form of a PRP gel.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Delhi, India, 110025
- Fortis Escorts Heart Institute and Research Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or Female 18 to 85 years of age
- Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic foot ulcer) which is at least 4 weeks old
- Index foot ulcer located on the plantar, medial or lateral aspect of the foot (including all toe surfaces)
- Wound area (length x width) measurement must be between 0.5 cm^2 and 10 cm^2, inclusive
- If more than one non-healing ulcers is present, the largest wound will be selected
- Index ulcer must be clinically non-infected
- Full-thickness ulcer without exposure of bone, muscle, ligament or tendon
- Written informed consent must be obtained from either the patient or the patients legally acceptable representative prior to enrollment
Exclusion Criteria:
- Patients with known sensitivity to components of the PRP kit (calcium chloride, thrombin, acid citrate dextrose solution A (ACD-A))
- Smokers and individuals with systemic disease or history of anticoagulant, immuno-suppressive or antibiotic therapy in the last 3 months
- Platelet count < 105 x 10^3/ uL (according to CBC)
- Hemoglobin level < 10 g/dL (according to CBC)
- Wound is clinically infected
- Presence of platelet dysfunction syndrome or critical thrombocytopenia
- Bleeding disorders, collagen vascular disease or severe cardiovascular disorder
- Any malignancy other than non-melanoma skin cancer
- Patient is currently receiving or has received radiation or chemotherapy within 3 months prior to treatment
- If female, patient is pregnant, nursing or plans to become pregnant during the duration of the study
- Subject has inadequate venous access for blood draw required for PRP preparation
- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
- Subject is on dialysis or has uncontrolled sugar levels
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Autologous PRP Gel and PRP Injection
Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side.
The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.
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Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer. Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound. Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Wound/ Ulcers Healed
Periodo de tiempo: 24 weeks
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The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy
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24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time to Ulcer Healing
Periodo de tiempo: 24 weeks
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The average time taken for the ulcers to heal post PRP administration
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24 weeks
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Reduction in Pain using VAS pain score
Periodo de tiempo: 24 weeks
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Improvement in Pain and discomfort following PRP therapy
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24 weeks
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Changes in Quality of Life using the SF-36 Questionnaire
Periodo de tiempo: 24 weeks
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Improvement in Quality of Life of the patients following PRP therapy
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24 weeks
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Number of participants with treatment-related Adverse Events
Periodo de tiempo: 24 weeks
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Safety of the treatment will be assessed by measuring the number of treatment related adverse events and adverse reactions during the follow-up period
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24 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dr. Suhail N Bukhari, MBBS, DNB, Fortis Escorts Heart Institute and Research Centre
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TPRX/PRP/NHU/141005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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