Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750837
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-02-07
Brief Title:
Platelet Rich Plasma and Diabetic Foot Ulcer
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Autologous Platelet-Rich Plasma Versus Conventional Dressing Method in the Treatment of Chronic Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In chronic diabetic foot ulcer if the conventional dressing fails new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial but the cost is a limiting factor Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors
Detailed Description:
The term chronic wound was first used in literature in the 1950s to refer to wounds that were difficult to heal or did not follow a normal healing process However the term has met criticism for its uncertainty regarding the duration of chronicity Martin Nunan 2015 defined a chronic wound as a barrier defect that has not healed in 3 months and Leaper Durani 2008 defined it as a wound that lacks a 20-40 reduction in its size after 2-4 weeks of optimal treatment or when there is no complete healing after 6 weeks Recent reviews have highlighted the lack of consensus regarding the definition of a chronic wound and the need for further researches in this area
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome This medical condition affects 15 of all patients with diabetes mellitus Alvarsson et al in 2012 reported that up to 88 of all lower leg amputations were related to diabetic foot ulcers
The impact of chronic wounds on the health and quality of patients life and their families should not be underestimated Patients with chronic wounds may experience chronic pain loss of function and mobility depression and anxiety increased social stress and isolation prolonged hospitalization increased financial burden and increased morbidity and mortality
Growth factors GFs play an essential role in the process of wound healing and tissue regeneration Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells Growth factors effects include promoting chemotaxis inducing cell migration and proliferation and stimulate cells to upregulate protein production These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix creating an ideal environment that favors the cutaneous wound healing process
Over the last decades the use of emerging cellular therapies such as platelet-rich plasma PRP has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized quality treatment plan
PRP is defined as plasma containing above-baseline concentrations of platelets which is from 140 000-400 000μl PRP is isolated through the centrifugation of whole blood Simply its actions are based on the infusion of elevated platelets thereby theoretically enhancing the biological healing capacity and tissue generation in the wound bed Enzyme-linked immunosorbent assay studies of PRP have quantified the presence of increases in GFs such as transforming GF β epidermal GF and platelet-derived GF Through degranulation of the alpha granules in platelets PRP can secrete various GFs which have been documented to initiate the wound healing process
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome This medical condition affects 15 of all patients with diabetes mellitus Alvarsson et al in 2012 reported that up to 88 of all lower leg amputations were related to diabetic foot ulcers
The impact of chronic wounds on the health and quality of patients life and their families should not be underestimated Patients with chronic wounds may experience chronic pain loss of function and mobility depression and anxiety increased social stress and isolation prolonged hospitalization increased financial burden and increased morbidity and mortality
Growth factors GFs play an essential role in the process of wound healing and tissue regeneration Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells Growth factors effects include promoting chemotaxis inducing cell migration and proliferation and stimulate cells to upregulate protein production These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix creating an ideal environment that favors the cutaneous wound healing process
Over the last decades the use of emerging cellular therapies such as platelet-rich plasma PRP has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized quality treatment plan
PRP is defined as plasma containing above-baseline concentrations of platelets which is from 140 000-400 000μl PRP is isolated through the centrifugation of whole blood Simply its actions are based on the infusion of elevated platelets thereby theoretically enhancing the biological healing capacity and tissue generation in the wound bed Enzyme-linked immunosorbent assay studies of PRP have quantified the presence of increases in GFs such as transforming GF β epidermal GF and platelet-derived GF Through degranulation of the alpha granules in platelets PRP can secrete various GFs which have been documented to initiate the wound healing process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None