Nutrition Impact on PRGF Treatment for Tendinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet rich growth factor injection (autologous product).
- Who it may be relevant to
- Registry conditions: Shoulder Tendinopathy, Metabolic Alterations. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
Overview
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.
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-Sant'Ambrogio 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 18.5 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 BMI\>25, 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 (e.g. resistin, P-selectin, interleukins etc.).
Interventions
- Biological Platelet rich growth factor injection (autologous product)
All patients will undergo two PRGF injections, one at recruitment and one 14 days after the first injection. The injection site will be the shoulder with tendinopathy.
Primary outcome measures
- Responder and non-responder patient identification at 6 months follow-up. [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: complete blood count [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: blood glucose [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c) [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: urea [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: creatinine [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: siderosis [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: tryglicerides [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: cholesterol [Time frame: 0-24 months]
- Identification of nutritional status of responder and non-responder patients: Cholesterol HDL [Time frame: 0-24 months]
Secondary outcome measures (8)
- Responder and non-responder patient identification at 2 months follow-up. [Time frame: 2-26 months]
- Responder and non-responder patient identification at 12 months follow-up. [Time frame: 12-36 months]
- The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count [Time frame: 24-26 months]
- The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification [Time frame: 24-26 months]
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8 [Time frame: 24-26 months]
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF [Time frame: 24-26 months]
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin [Time frame: 24-26 months]
- The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin [Time frame: 24-26 months]
Eligibility criteria
Inclusion criteria
- Male and female
- Age ≥18 years and ≤ 70 years
- Patients presenting shoulder tendinopathy
- Signing of the Informed Consent of the Regain observational study
- Signature of informed consent of the present study.
Exclusion criteria
- Pregnancy (ascertained by self-declaration), breastfeeding
- Inability to follow the study protocol
- Heart, kidney, oncological disease
- Neuropsychiatric disease
- Other conditions that, at the discretion of the investigator or physician, exclude enrollement
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio — Milan
Identifiers
NCT: NCT06536582 · NUTRITENDON · 5xmille 2021CUPC43C2200237000 · L1054 Ricerca corrente