Cohort Study of PPP Injections for Athletes With Muscle Injury

Part of paid clinical trials in Englewood, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07566039
Status
Not Yet Recruiting

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Conditions

  • Lower Extremity Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PPP Injection Treated Arm
    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.
  • No Intervention: No Injection Arm
    Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado | Steadman Hawkins Clinic DenverEnglewoodColorado80112
Jason L Dragoo, MD
[email protected]
720-872-4836
Inverness Clinical Trials
[email protected]
720-872-4836
Emory UniversityAtlantaGeorgia30322-
University of IowaIowa CityIowa52242-

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University of Colorado | Steadman Hawkins Clinic Denver· Englewood, COEmory University· Atlanta, GAUniversity of Iowa· Iowa City, IA

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