Cohort Study of PPP Injections for Athletes With Muscle Injury

ConditionLower Extremity Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorUniversity of Colorado, Denver

About this trial

The investigators hypothesize that a single injection of platelet-poor plasma (PPP) into an acute muscle injury will significantly improve local muscle regeneration and patient outcomes compared to the standard of care using only ultrasound-guided hematoma aspiration. Muscle regeneration will be assessed through quantitative MRI analysis. The investigators anticipate that PPP injections will lead to a measurable reduction in scar tissue and an increase in regenerated muscle tissue at the injury site over a six-month period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 45 years

Diagnosis of a muscle strain in the lower extremities, including but not limited to hamstring, quadriceps, and gastrocnemius

Injury occurred within 10 days of the initial clinical evaluation

Injury occurred while engaging in athletic or sporting activities

Disqualifiers

Previous injection at the injury site.

Pregnant or breastfeeding women, or women who may become pregnant during the study duration

Injuries resulting from puncture or crush trauma

Injuries occurring more than 10 days prior to the injection date

Trial design

Design model

Parallel

Treatments tested in this trial

Platelet Poor Plasma (PPP) Injection
Device
US-guided aspiration of hematoma (if present) and injection of small volume (1-6cc's) of autologous platelet poor plasma (PPP) at the site of injury and post-injection physical therapy.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: PPP Injection Treated ArmExperimental treatment 1 intervention

Group B: No Injection ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Scar Tissue Volume at the Muscle Injury Site as Measured by Quantitative MRI Mapping

Scar tissue volume at the site of acute muscle injury will be measured using quantitative mapping magnetic resonance imaging (MRI). MRI images will be segmented using software to identify abnormal (scar) tissue within the injured muscle. Scar tissue volume will be calculated in cubic centimeters (cm³). This outcome measure represents the change in scar tissue volume, calculated as the difference between baseline MRI and 6-month follow-up MRI measurements. A lower scar tissue volume indicates greater muscle regeneration and reduced fibrosis.

Time frame

Baseline MRI and 6-month follow-up MRI

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Emory University

Collaborator

University of Iowa

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: