Nutrition Impact on PRGF Treatment for Tendinopathy
- Conditions
- Shoulder TendinopathyMetabolic Alterations
- Interventions
- Biological: Platelet rich growth factor injection (autologous product)
- Registration Number
- NCT06536582
- Lead Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- 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.
- 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.).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal weight patients Platelet rich growth factor injection (autologous product) 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF. Over weight patients Platelet rich growth factor injection (autologous product) 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI\>25, who undergo the PRGF treatment
- Primary Outcome Measures
Name Time Method Anthropometric measurement: weight 0-24 months weight (kg) measurement
Identification of nutritional status of responder and non-responder patients: cholesterol 0-24 months Cholesterol (mg/dl)
Identification of nutritional status of responder and non-responder patients: calcium 0-24 months Calcium: mg/dl
Identification of nutritional status of responder and non-responder patients: vitamin B 12 0-24 months Vitamin B 12 (pg/ml)
Anthropometric measurement: height 0-24 months height (m) measurement
Anthropometric measurement: subscapular folds measurement 0-24 months subscapular folds measurement (mm)
Anthropometric measurement: suprailiac folds measurement 0-24 months suprailiac folds measurement (mm)
Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase 0-24 months Glutamate-oxaloacetate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH) 0-24 months Vitamin D (25 OH): ng/ml
Anthropometric measurement: biceps folds measurement 0-24 months biceps folds measurement (mm)
Identification of nutritional status of responder and non-responder patients: blood glucose 0-24 months Blood glucose (mg/dl)
Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c) 0-24 months Hemoglobin A1C (HbA1c): mmol/mol
Identification of nutritional status of responder and non-responder patients: creatinine 0-24 months Creatinine: mg/dl
Identification of nutritional status of responder and non-responder patients: siderosis 0-24 months siderosis: ug/dl
Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase 0-24 months Glutamate-pyruvate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: gamma GT 0-24 months Gamma GT: U/l
Identification of nutritional status of responder and non-responder patients: ferritin 0-24 months Ferritin (ng/ml)
Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH) 0-24 months thyroid stimulating hormone (TSH): uIU/ml
Identification of nutritional status of responder and non-responder patients: Folates 0-24 months Folates (ng/ml)
Anthropometric measurement: waist circumference 0-24 months waist circumference (cm) measurement
Anthropometric measurement: triceps folds measurement 0-24 months triceps folds measurement (mm)
Responder and non-responder patient identification at 6 months follow-up. 0-24 months The primary objective of this study is to identify the proportion of responder and non-responder patients with shoulder tendinopathy to treatment with orthobiological "Platelet rich growth factors" PRGF at six month follow up. Responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI, WOOS scores, and Work index.
Identification of nutritional status of responder and non-responder patients: complete blood count 0-24 months Complete blood count (cell number/dl)
Identification of nutritional status of responder and non-responder patients: tryglicerides 0-24 months tryglicerides (mg/dl)
Identification of nutritional status of responder and non-responder patients: Cholesterol HDL 0-24 months Cholesterol HDL (mg/dl)
Identification of nutritional status of responder and non-responder patients: Insulin 0-24 months Insulin: uU/ml
Anthropometric measurement: arm circumference measurements 0-24 months arm circumference measurements (cm)
Identification of nutritional status of responder and non-responder patients: urea 0-24 months Urea: mg/dl
Identification of nutritional status of responder and non-responder patients: 0-24 months C reactive protein: (mg/dl)
- Secondary Outcome Measures
Name Time Method The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin 24-26 months Quantitative analysis of P-selectin: pg/ml
The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification 24-26 months Identification of extracellular vesicles markers: Arbitrary Fluorescence Unit
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin 24-26 months Quantitative analysis of resistin: pg/ml
Responder and non-responder patient identification at 2 months follow-up. 2-26 months The secondary objectives of the study will be:
to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at two months follow up. 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.The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count 24-26 months extracellular vesicles count: number/ml
Responder and non-responder patient identification at 12 months follow-up. 12-36 months The secondary objectives of the study will be:
to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at twelve months follow up. 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.The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8 24-26 months Quantitative analysis of cytokines (CXCL8): pg/ml
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF 24-26 months Quantitative analysis of growth factors: G-CSF (pg/ml)
Trial Locations
- Locations (1)
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
🇮🇹Milan, Italy