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NCT Number: NCT07566039

Cohort Study of PPP Injections for Athletes With Muscle Injury

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado | Steadman Hawkins Clinic Denver, Englewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Participants must be willing to undergo prescribed physical therapy
  • Participants have agreed to standard-of-care management for their injury, which may include ultrasound-guided aspiration with or without a platelet-poor plasma injection

Exclusion criteria

  • 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
  • Injuries not caused by athletic or sporting activity
  • Previous muscle injury in the same muscle group within 6 months

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline MRI and 6-month follow-up MRI

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Inverness Clinical Trials

CONTACT

[email protected]

Jason L Dragoo, MD

CONTACT

[email protected]

303-724-1055

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Emory University
  • University of Iowa

Registry information

Official study title

Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 4, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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