"STUDY TO ASSES A DERIVATIVE HEMATOLOGIC TREATMENT IN ACUTE MUSCLE INJURIES IN ELITE ATHLETES"

CLINICAL STUDY TO ASSES THERAPEUTIC USE OF PLATELET RICH PLASMA IN ACUTE MUSCLE INJURIES IN ELITE ATHLETES" - USE OF PLATELET RICH PLASMA IN ACUTE MUSCLE INJURIES

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004140-32-ES

Enrollment

Registered

2013-12-05

Start date

2014-04-28

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Muscle Injury Type 3A-3B (Munich classification) or type II (Classification of Otto Chan), confirmed by radiological diagnosis and clinical agreement. MedDRA version: 17.0 Level: PT Classification code 10028391 Term: Musculoskeletal pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: PRP (OBTENIDO POR PRGF-ENDORET) Pharmaceutical Form: Solution for injection INN or Proposed INN: PRGF-ENDORET Other descriptive name: AUTO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Over 18 years. - Acute Muscle Injury Type 3A-3B (Munich classification) or type II (Classification of Otto Chan), confirmed by radiological diagnosis and clinical agreement. - Informed consent. Rated and signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - prior infiltration of corticosteroids or plasma for hamstring or quadriceps in the 6 months prior to baseline.

Design outcomes

Primary

Measure	Time frame
Main Objective: OBJECTIVES main Objectives ? To evaluate the short-term efficacy of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the number of days that elapse from the onset of the injury until returning to sporting competition in each of the groups. ? To evaluate the short-term safety of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the percentage of adverse reactions collected in each of the groups. ? Evaluation of the number of relapses after an acute muscle injury grade II in the intervention group compared to control. ; Secondary Objective: ? Establish a prognostic index LEZAMA called INDEX. For this the end of the study aims to establish a prognostic value in DAYS recovery period in severe acute muscle injury (grade II), treated with 2 injections of PRP, and taking into account the following variables: the muscle group affected location frequency, radiological imaging, force mobility, pain, and functional self-perception. ? Composition of PRP: help establish the best composition of the PRP, by analyzing different molecules directly involved in muscle repair (standardization of formulations). ? description radiological evolution of muscle injury and repair quality through serial MRI. ? Found data will be compared with the historical group of the last decade of the different teams, and in relation to the data published in the scientific literature. ; Primary end point(s): RECOVERY PERIOD . Days since muscle injury to return to full training with the rest of the class . For this, the player will be	—

Measure

Time frame

Main Objective: OBJECTIVES main Objectives ? To evaluate the short-term efficacy of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the number of days that elapse from the onset of the injury until returning to sporting competition in each of the groups. ? To evaluate the short-term safety of intramuscular infiltration (guided by ultrasound) of PRP plus physiotherapy from infiltration of Traumeel ® plus physiotherapy in the treatment of acute muscle injury grade II, by measuring the percentage of adverse reactions collected in each of the groups. ? Evaluation of the number of relapses after an acute muscle injury grade II in the intervention group compared to control. ; Secondary Objective: ? Establish a prognostic index LEZAMA called INDEX. For this the end of the study aims to establish a prognostic value in DAYS recovery period in severe acute muscle injury (grade II), treated with 2 injections of PRP, and taking into account the following variables: the muscle group affected location frequency, radiological imaging, force mobility, pain, and functional self-perception. ? Composition of PRP: help establish the best composition of the PRP, by analyzing different molecules directly involved in muscle repair (standardization of formulations). ? description radiological evolution of muscle injury and repair quality through serial MRI. ? Found data will be compared with the historical group of the last decade of the different teams, and in relation to the data published in the scientific literature. ; Primary end point(s): RECOVERY PERIOD . Days since muscle injury to return to full training with the rest of the class . For this, the player will be

—

Secondary

Measure	Time frame
Secondary end point(s): Record any iatrogenic; Timepoint(s) of evaluation of this end point: Quadriceps: Baseline and after 10 days. If the lesion requires: 13,16 or 19 days Hamstrings: Basal, at 18 days. If the lesion requires: 21,24 or 27	—

Countries

Spain

Contacts

Public ContactJORGE GUADILLA ARSUAGA

OSAKIDETZA

javi.g.iglesias@gmail.com0034946006637

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026