Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536582
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-19
Brief Title:
Nutrition Impact on PRGF Treatment for Tendinopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUTRITENDON
Brief Summary:
Given the close correlation reported in the literature between onset and progression of tendon pathology in subjects affected by the alteration of metabolic disorders such as obesity diabetes mellitus and lipidic metabolic alterations with the present study the association between the nutritional state metabolic profile and clinical outcome of patients following treatment with blood-derived orthobiological for shoulder tendinopathies will be evaluated
The primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with Platelet rich growth factors PRGF at six months follow up and the correlation with their nutritional status
The primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with Platelet rich growth factors PRGF at six months follow up and the correlation with their nutritional status
Detailed Description:
This is a single-center observational study with an additional procedure extra blood sampling routine food questionnaires anthropometric measurements for the evaluation of nutritional status prospective uncontrolled
Male and female patients between 18 and 70 years old suffering from tendinopathy of the shoulder who undergo conservative regenerative medicine procedures with autologous PRGF material at the IRCCS Galeazzi-SantAmbrogio Hospital of Milan and participants in the observational study Use of Patient- Reported Outcome Measures PROMs objective clinical assessments and biomolecular technologies for monitoring patients undergoing treatments regenerative medicine REGAIN will be enrolled for this study
46 patients will be needed
1 23 subjects with body mass index BMI between 185 and 25 therefore considered normal weight who undergo treatment with PRGF
2 23 subjects with BMI values that exceed the considered range normal weight therefore with BMI25 who undergo the PRGF treatment
The general aim of the present study is to evaluate the correlation between the nutritional status of patients the characteristics of the orthobiological product used for the treatment of shoulder tendon pathology and clinical outcomes after one-step conservative regenerative medicine treatment with PRGF in order to identify the ideal nutritional conditions to obtain the best clinical outcome from this type of treatment
The primary objective of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with orthobiological Platelet rich growth factors PRGF at six month follow up and the correlation with their nutritional status To this end responsive patients and non-responsive will be identified on the basis of the results of the VAS ASES Quick Dash SPADI WOOS scores and Work index
The secondary objectives of the study will be
1 to Identify the proportion of responsive and non-responsive patients presenting shoulder tendinopathy to treatment with orthobiological Platelet rich growth factors PRGF at two and twelve months follow up and the correlation with their nutritional status For this purpose responsive and non-responsive patients will be identified on the basis of the results of the VAS ASES Quick Dash SPADI scores WOOS and Work index
Characterization of the PRGF product used for the treatment of each patient that will occur by qualitative and quantitative analysis of the content in extracellular vesicles analysis of a panel of cytokines chemokines and growth factors linked to inflammation and correlated to the state nutritional information of patients eg resistin P-selectin interleukins etc
Male and female patients between 18 and 70 years old suffering from tendinopathy of the shoulder who undergo conservative regenerative medicine procedures with autologous PRGF material at the IRCCS Galeazzi-SantAmbrogio Hospital of Milan and participants in the observational study Use of Patient- Reported Outcome Measures PROMs objective clinical assessments and biomolecular technologies for monitoring patients undergoing treatments regenerative medicine REGAIN will be enrolled for this study
46 patients will be needed
1 23 subjects with body mass index BMI between 185 and 25 therefore considered normal weight who undergo treatment with PRGF
2 23 subjects with BMI values that exceed the considered range normal weight therefore with BMI25 who undergo the PRGF treatment
The general aim of the present study is to evaluate the correlation between the nutritional status of patients the characteristics of the orthobiological product used for the treatment of shoulder tendon pathology and clinical outcomes after one-step conservative regenerative medicine treatment with PRGF in order to identify the ideal nutritional conditions to obtain the best clinical outcome from this type of treatment
The primary objective of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with orthobiological Platelet rich growth factors PRGF at six month follow up and the correlation with their nutritional status To this end responsive patients and non-responsive will be identified on the basis of the results of the VAS ASES Quick Dash SPADI WOOS scores and Work index
The secondary objectives of the study will be
1 to Identify the proportion of responsive and non-responsive patients presenting shoulder tendinopathy to treatment with orthobiological Platelet rich growth factors PRGF at two and twelve months follow up and the correlation with their nutritional status For this purpose responsive and non-responsive patients will be identified on the basis of the results of the VAS ASES Quick Dash SPADI scores WOOS and Work index
Characterization of the PRGF product used for the treatment of each patient that will occur by qualitative and quantitative analysis of the content in extracellular vesicles analysis of a panel of cytokines chemokines and growth factors linked to inflammation and correlated to the state nutritional information of patients eg resistin P-selectin interleukins etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None