Shoulder TendinopathyNUTRITENDONNCT06536582
Nutrition Impact on PRGF Treatment for Tendinopathy
An observational study of Shoulder Tendinopathy and Metabolic Alterations, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Tendinopathy, Metabolic Alterations
- What is being tested?
- Platelet rich growth factor injection (autologous product)
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2024to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female patients, between 18 and 70 years old suffering from shoulder tendinopathy undergoing a conservative regenerative medicine procedure with autologous PRGF at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants at the observational study "Use of patients- Reported Outcome Measures (PROM), 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Milan, 20173
Elena Cittera, 00390283502224, elena.cittera@grupposandonato.it
Paola De Luca
About this study
Official title: Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
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.
Read the 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:
- 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF;
- 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:
- 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.).
- Conditions
- Shoulder Tendinopathy, Metabolic Alterations
- Being tested
- Platelet rich growth factor injection (autologous product)
- Keywords
- nutritional status, responder and non-responder patients, orthobiologics, Platelet rich growth factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich growth factor injection (autologous product)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight patients | 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF. Receives: Biological: Platelet rich growth factor injection (autologous product) | |
| Over weight patients | 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI>25, who undergo the PRGF treatment Receives: Biological: Platelet rich growth factor injection (autologous product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder and non-responder patient identification at 6 months follow-up.
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.
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: complete blood count
Complete blood count (cell number/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: blood glucose
Blood glucose (mg/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c)
Hemoglobin A1C (HbA1c): mmol/mol
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: urea
Urea: mg/dl
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: creatinine
Creatinine: mg/dl
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: siderosis
siderosis: ug/dl
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: tryglicerides
tryglicerides (mg/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: cholesterol
Cholesterol (mg/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Cholesterol HDL
Cholesterol HDL (mg/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase
Glutamate-oxaloacetate transaminase: (U/l)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase
Glutamate-pyruvate transaminase: (U/l)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: gamma GT
Gamma GT: U/l
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: calcium
Calcium: mg/dl
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH)
Vitamin D (25 OH): ng/ml
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: ferritin
Ferritin (ng/ml)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients:
C reactive protein: (mg/dl)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH)
thyroid stimulating hormone (TSH): uIU/ml
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Insulin
Insulin: uU/ml
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: Folates
Folates (ng/ml)
Measured: 0-24 months
Identification of nutritional status of responder and non-responder patients: vitamin B 12
Vitamin B 12 (pg/ml)
Measured: 0-24 months
Anthropometric measurement: weight
weight (kg) measurement
Measured: 0-24 months
Anthropometric measurement: height
height (m) measurement
Measured: 0-24 months
Anthropometric measurement: waist circumference
waist circumference (cm) measurement
Measured: 0-24 months
Anthropometric measurement: arm circumference measurements
arm circumference measurements (cm)
Measured: 0-24 months
Anthropometric measurement: biceps folds measurement
biceps folds measurement (mm)
Measured: 0-24 months
Anthropometric measurement: triceps folds measurement
triceps folds measurement (mm)
Measured: 0-24 months
Anthropometric measurement: subscapular folds measurement
subscapular folds measurement (mm)
Measured: 0-24 months
Anthropometric measurement: suprailiac folds measurement
suprailiac folds measurement (mm)
Measured: 0-24 months
Secondary outcomes (8)
Responder and non-responder patient identification at 2 months follow-up.
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.
Measured: 2-26 months
Responder and non-responder patient identification at 12 months follow-up.
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.
Measured: 12-36 months
The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count
extracellular vesicles count: number/ml
Measured: 24-26 months
The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification
Identification of extracellular vesicles markers: Arbitrary Fluorescence Unit
Measured: 24-26 months
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8
Quantitative analysis of cytokines (CXCL8): pg/ml
Measured: 24-26 months
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF
Quantitative analysis of growth factors: G-CSF (pg/ml)
Measured: 24-26 months
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin
Quantitative analysis of resistin: pg/ml
Measured: 24-26 months
The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin
Quantitative analysis of P-selectin: pg/ml
Measured: 24-26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Feb 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder TendinopathyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536582
- Sponsor's protocol ID
- NUTRITENDON
- Other IDs
- 5xmille 2021CUPC43C2200237000, L1054 Ricerca corrente
- Acronym
- NUTRITENDON
- Status last verified
- Jul 2024
- First submitted
- 19 Mar 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
- ClinicalTrials.gov ID
- NCT06536582
- Acronym / sponsor ID
- NUTRITENDON / NUTRITENDON
- Conditions
- Shoulder Tendinopathy, Metabolic Alterations
- Keywords
- nutritional status, responder and non-responder patients, orthobiologics, Platelet rich growth factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF;
- 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:
- 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.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight patients | – | Biological: 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 | – | Biological: 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients, between 18 and 70 years old suffering from shoulder tendinopathy undergoing a conservative regenerative medicine procedure with autologous PRGF at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants at the observational study "Use of patients- Reported Outcome Measures (PROM), 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Normal weight patients, Over weight patients |
Primary outcome
Responder and non-responder patient identification at 6 months follow-up.
Time frame: 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
Time frame: 0-24 months
Complete blood count (cell number/dl)
Identification of nutritional status of responder and non-responder patients: blood glucose
Time frame: 0-24 months
Blood glucose (mg/dl)
Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c)
Time frame: 0-24 months
Hemoglobin A1C (HbA1c): mmol/mol
Identification of nutritional status of responder and non-responder patients: urea
Time frame: 0-24 months
Urea: mg/dl
Identification of nutritional status of responder and non-responder patients: creatinine
Time frame: 0-24 months
Creatinine: mg/dl
Identification of nutritional status of responder and non-responder patients: siderosis
Time frame: 0-24 months
siderosis: ug/dl
Identification of nutritional status of responder and non-responder patients: tryglicerides
Time frame: 0-24 months
tryglicerides (mg/dl)
Identification of nutritional status of responder and non-responder patients: cholesterol
Time frame: 0-24 months
Cholesterol (mg/dl)
Identification of nutritional status of responder and non-responder patients: Cholesterol HDL
Time frame: 0-24 months
Cholesterol HDL (mg/dl)
Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase
Time frame: 0-24 months
Glutamate-oxaloacetate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase
Time frame: 0-24 months
Glutamate-pyruvate transaminase: (U/l)
Identification of nutritional status of responder and non-responder patients: gamma GT
Time frame: 0-24 months
Gamma GT: U/l
Identification of nutritional status of responder and non-responder patients: calcium
Time frame: 0-24 months
Calcium: mg/dl
Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH)
Time frame: 0-24 months
Vitamin D (25 OH): ng/ml
Identification of nutritional status of responder and non-responder patients: ferritin
Time frame: 0-24 months
Ferritin (ng/ml)
Identification of nutritional status of responder and non-responder patients:
Time frame: 0-24 months
C reactive protein: (mg/dl)
Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH)
Time frame: 0-24 months
thyroid stimulating hormone (TSH): uIU/ml
Identification of nutritional status of responder and non-responder patients: Insulin
Time frame: 0-24 months
Insulin: uU/ml
Identification of nutritional status of responder and non-responder patients: Folates
Time frame: 0-24 months
Folates (ng/ml)
Identification of nutritional status of responder and non-responder patients: vitamin B 12
Time frame: 0-24 months
Vitamin B 12 (pg/ml)
Anthropometric measurement: weight
Time frame: 0-24 months
weight (kg) measurement
Anthropometric measurement: height
Time frame: 0-24 months
height (m) measurement
Anthropometric measurement: waist circumference
Time frame: 0-24 months
waist circumference (cm) measurement
Anthropometric measurement: arm circumference measurements
Time frame: 0-24 months
arm circumference measurements (cm)
Anthropometric measurement: biceps folds measurement
Time frame: 0-24 months
biceps folds measurement (mm)
Anthropometric measurement: triceps folds measurement
Time frame: 0-24 months
triceps folds measurement (mm)
Anthropometric measurement: subscapular folds measurement
Time frame: 0-24 months
subscapular folds measurement (mm)
Anthropometric measurement: suprailiac folds measurement
Time frame: 0-24 months
suprailiac folds measurement (mm)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Tendinopathy and Metabolic Alterations, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola De Luca, PhD (+39 3921385179, deluca.paola@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder and non-responder patient identification at 6 months follow-up. (time frame: 0-24 months). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.