Cohort Study of PPP Injections for Athletes With Muscle Injury

NCT07566039 | Not Yet Recruiting FDA Device

• 1 other identifier: 22-1841
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lower Extremity Injury

Keywords

Lower extremity injury; PPP injection; Platelet Poor Plasma injection; Athlete; muscle injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline MRI and 6-month follow-up MRI

Study Arms (2)

PPP Injection Treated Arm

EXPERIMENTAL

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.

Device: Platelet Poor Plasma (PPP) Injection

No Injection Arm

NO INTERVENTION

Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only.

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.

PPP Injection Treated Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Emory University: collaborator
• University of Iowa: collaborator

Study Sites (3)

University of Colorado | Steadman Hawkins Clinic Denver

Englewood, Colorado, 80112, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (34)

• Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK. Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. J Extra Corpor Technol. 2007 Sep;39(3):177-82.

  PMID: 17972452 BACKGROUND

• Yilmaz S, Kabadayi C, Ipci SD, Cakar G, Kuru B. Treatment of intrabony periodontal defects with platelet-rich plasma versus platelet-poor plasma combined with a bovine-derived xenograft: a controlled clinical trial. J Periodontol. 2011 Jun;82(6):837-44. doi: 10.1902/jop.2010.100503. Epub 2010 Dec 7.

  PMID: 21138357 BACKGROUND

• Thierfelder KM, Gerhardt JS, Gemescu IN, Notohamiprodjo S, Rehnitz C, Weber MA. Imaging of hip and thigh muscle injury: a pictorial review. Insights Imaging. 2019 Feb 15;10(1):20. doi: 10.1186/s13244-019-0702-1.

  PMID: 30771029 BACKGROUND

• Tchkonia T, Zhu Y, van Deursen J, Campisi J, Kirkland JL. Cellular senescence and the senescent secretory phenotype: therapeutic opportunities. J Clin Invest. 2013 Mar;123(3):966-72. doi: 10.1172/JCI64098. Epub 2013 Mar 1.

  PMID: 23454759 BACKGROUND

• Stevens KJ, Crain JM, Akizuki KH, Beaulieu CF. Imaging and ultrasound-guided steroid injection of internal oblique muscle strains in baseball pitchers. Am J Sports Med. 2010 Mar;38(3):581-5. doi: 10.1177/0363546509350105. Epub 2010 Jan 5.

  PMID: 20051499 BACKGROUND

• Shahidi M, Vatanmakanian M, Arami MK, Sadeghi Shirazi F, Esmaeili N, Hydarporian S, Jafari S. A comparative study between platelet-rich plasma and platelet-poor plasma effects on angiogenesis. Med Mol Morphol. 2018 Mar;51(1):21-31. doi: 10.1007/s00795-017-0168-5. Epub 2017 Sep 25.

  PMID: 28948378 BACKGROUND

• Setayesh K, Villarreal A, Gottschalk A, Tokish JM, Choate WS. Treatment of Muscle Injuries with Platelet-Rich Plasma: a Review of the Literature. Curr Rev Musculoskelet Med. 2018 Dec;11(4):635-642. doi: 10.1007/s12178-018-9526-8.

  PMID: 30343400 BACKGROUND

• Otrocka-Domagala I, Pazdzior-Czapula K, Gesek M. Dexamethasone-induced impairment of post-injury skeletal muscle regeneration. BMC Vet Res. 2019 Feb 11;15(1):56. doi: 10.1186/s12917-019-1804-1.

  PMID: 30744624 BACKGROUND

• Mueller-Wohlfahrt HW, Haensel L, Mithoefer K, Ekstrand J, English B, McNally S, Orchard J, van Dijk CN, Kerkhoffs GM, Schamasch P, Blottner D, Swaerd L, Goedhart E, Ueblacker P. Terminology and classification of muscle injuries in sport: the Munich consensus statement. Br J Sports Med. 2013 Apr;47(6):342-50. doi: 10.1136/bjsports-2012-091448. Epub 2012 Oct 18.

  PMID: 23080315 BACKGROUND

• Miroshnychenko O, Chang WT, Dragoo JL. The Use of Platelet-Rich and Platelet-Poor Plasma to Enhance Differentiation of Skeletal Myoblasts: Implications for the Use of Autologous Blood Products for Muscle Regeneration. Am J Sports Med. 2017 Mar;45(4):945-953. doi: 10.1177/0363546516677547. Epub 2016 Dec 27.

  PMID: 28027451 BACKGROUND

• Malahias MA, Mavrogenis AF, Nikolaou VS, Megaloikonomos PD, Kazas ST, Chronopoulos E, Babis GC. Similar effect of ultrasound-guided platelet-rich plasma versus platelet-poor plasma injections for chronic plantar fasciitis. Foot (Edinb). 2019 Mar;38:30-33. doi: 10.1016/j.foot.2018.11.003. Epub 2018 Nov 28.

  PMID: 30572281 BACKGROUND

• Liu W, Wang D, Ouyang H, Chen N, Chang B, Zhu Q, Li J. Ultrasound Assessment of Muscle Injury Associated with Closed Limb Fracture. Biomed Res Int. 2019 Jun 11;2019:9365291. doi: 10.1155/2019/9365291. eCollection 2019.

  PMID: 31309121 BACKGROUND

• Levine WN, Bergfeld JA, Tessendorf W, Moorman CT 3rd. Intramuscular corticosteroid injection for hamstring injuries. A 13-year experience in the National Football League. Am J Sports Med. 2000 May-Jun;28(3):297-300. doi: 10.1177/03635465000280030301.

  PMID: 10843118 BACKGROUND

• Lee JC, Mitchell AW, Healy JC. Imaging of muscle injury in the elite athlete. Br J Radiol. 2012 Aug;85(1016):1173-85. doi: 10.1259/bjr/84622172. Epub 2012 Apr 11.

  PMID: 22496067 BACKGROUND

• Laberge RM, Zhou L, Sarantos MR, Rodier F, Freund A, de Keizer PL, Liu S, Demaria M, Cong YS, Kapahi P, Desprez PY, Hughes RE, Campisi J. Glucocorticoids suppress selected components of the senescence-associated secretory phenotype. Aging Cell. 2012 Aug;11(4):569-78. doi: 10.1111/j.1474-9726.2012.00818.x. Epub 2012 Apr 17.

  PMID: 22404905 BACKGROUND

• Kirkland JL, Tchkonia T. Senolytic drugs: from discovery to translation. J Intern Med. 2020 Nov;288(5):518-536. doi: 10.1111/joim.13141. Epub 2020 Aug 4.

  PMID: 32686219 BACKGROUND

• Kearney RS, Ji C, Warwick J, Parsons N, Brown J, Harrison P, Young J, Costa ML; ATM Trial Collaborators. Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial. JAMA. 2021 Jul 13;326(2):137-144. doi: 10.1001/jama.2021.6986.

  PMID: 34255009 BACKGROUND

• Kasitinon D, Dragoo JL, Hwang CE. Use of Platelet-Poor Plasma in Acute Quadriceps Muscle Strain in a Division I Football Placekicker: A Case Report. Curr Sports Med Rep. 2021 Nov 1;20(11):572-574. doi: 10.1249/JSR.0000000000000901. No abstract available.

  PMID: 34752428 BACKGROUND

• Huard J, Li Y, Fu FH. Muscle injuries and repair: current trends in research. J Bone Joint Surg Am. 2002 May;84(5):822-32. No abstract available.

  PMID: 12004029 BACKGROUND

• Hotfiel T, Seil R, Bily W, Bloch W, Gokeler A, Krifter RM, Mayer F, Ueblacker P, Weisskopf L, Engelhardt M. Nonoperative treatment of muscle injuries - recommendations from the GOTS expert meeting. J Exp Orthop. 2018 Jun 22;5(1):24. doi: 10.1186/s40634-018-0139-3.

  PMID: 29931565 BACKGROUND

• Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, Giorgadze N, Hashmi SK, Herrmann SM, Jensen MD, Jia Q, Jordan KL, Kellogg TA, Khosla S, Koerber DM, Lagnado AB, Lawson DK, LeBrasseur NK, Lerman LO, McDonald KM, McKenzie TJ, Passos JF, Pignolo RJ, Pirtskhalava T, Saadiq IM, Schaefer KK, Textor SC, Victorelli SG, Volkman TL, Xue A, Wentworth MA, Wissler Gerdes EO, Zhu Y, Tchkonia T, Kirkland JL. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease. EBioMedicine. 2019 Sep;47:446-456. doi: 10.1016/j.ebiom.2019.08.069. Epub 2019 Sep 18.

  PMID: 31542391 BACKGROUND

• Hamilton B, Valle X, Rodas G, Til L, Grive RP, Rincon JA, Tol JL. Classification and grading of muscle injuries: a narrative review. Br J Sports Med. 2015 Mar;49(5):306. doi: 10.1136/bjsports-2014-093551. Epub 2014 Nov 13.

  PMID: 25394420 BACKGROUND

• Hamilton B, Alonso JM, Best TM. Time for a paradigm shift in the classification of muscle injuries. J Sport Health Sci. 2017 Sep;6(3):255-261. doi: 10.1016/j.jshs.2017.04.011. Epub 2017 Apr 27.

  PMID: 30356632 BACKGROUND

• Hakim M, Hage W, Lovering RM, Moorman CT 3rd, Curl LA, De Deyne PG. Dexamethasone and recovery of contractile tension after a muscle injury. Clin Orthop Relat Res. 2005 Oct;439:235-42. doi: 10.1097/01.blo.0000177716.70404.f9.

  PMID: 16205165 BACKGROUND

• Guermazi A, Roemer FW, Robinson P, Tol JL, Regatte RR, Crema MD. Imaging of Muscle Injuries in Sports Medicine: Sports Imaging Series. Radiology. 2017 Mar;282(3):646-663. doi: 10.1148/radiol.2017160267.

  PMID: 28218878 BACKGROUND

• Grassi A, Quaglia A, Canata GL, Zaffagnini S. An update on the grading of muscle injuries: a narrative review from clinical to comprehensive systems. Joints. 2016 Jun 13;4(1):39-46. doi: 10.11138/jts/2016.4.1.039. eCollection 2016 Jan-Mar.

  PMID: 27386446 BACKGROUND

• Garg K, Corona BT, Walters TJ. Therapeutic strategies for preventing skeletal muscle fibrosis after injury. Front Pharmacol. 2015 Apr 21;6:87. doi: 10.3389/fphar.2015.00087. eCollection 2015.

  PMID: 25954202 BACKGROUND

• Floryan KM, Berghoff WJ. Intraoperative use of autologous platelet-rich and platelet-poor plasma for orthopedic surgery patients. AORN J. 2004 Oct;80(4):668-74, quiz 675-8. doi: 10.1016/s0001-2092(06)61320-3.

  PMID: 15526700 BACKGROUND

• Erfanian Y, Grueneisen J, Kirchner J, Wetter A, Podleska LE, Bauer S, Poeppel T, Forsting M, Herrmann K, Umutlu L. Integrated 18F-FDG PET/MRI compared to MRI alone for identification of local recurrences of soft tissue sarcomas: a comparison trial. Eur J Nucl Med Mol Imaging. 2017 Oct;44(11):1823-1831. doi: 10.1007/s00259-017-3736-y. Epub 2017 May 31.

  PMID: 28567495 BACKGROUND

• Drakos M, Birmingham P, Delos D, Barnes R, Murphy C, Weiss L, Warren R. Corticosteroid and Anesthetic Injections for Muscle Strains and Ligament Sprains in the NFL. HSS J. 2014 Jul;10(2):136-42. doi: 10.1007/s11420-014-9395-7. Epub 2014 May 21.

  PMID: 25050097 BACKGROUND

• Dorio M, Pereira RMR, Luz AGB, Deveza LA, de Oliveira RM, Fuller R. Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. BMC Musculoskelet Disord. 2021 Sep 24;22(1):822. doi: 10.1186/s12891-021-04706-7.

  PMID: 34560869 BACKGROUND

• Delos D, Maak TG, Rodeo SA. Muscle injuries in athletes: enhancing recovery through scientific understanding and novel therapies. Sports Health. 2013 Jul;5(4):346-52. doi: 10.1177/1941738113480934.

  PMID: 24459552 BACKGROUND

• Bentzinger CF, Wang YX, Dumont NA, Rudnicki MA. Cellular dynamics in the muscle satellite cell niche. EMBO Rep. 2013 Dec;14(12):1062-72. doi: 10.1038/embor.2013.182. Epub 2013 Nov 15.

  PMID: 24232182 BACKGROUND

• Batista JD, Justino Oliveira Limirio PH, Rocha FS, Gomes Moura CC, Zanetta-Barbosa D, Dechichi P. Influence of Platelet-Poor Plasma on Angiogenesis and Maintenance of Volume in Autogenous Bone Grafts. J Oral Maxillofac Surg. 2018 Oct;76(10):2097-2102. doi: 10.1016/j.joms.2018.06.024. Epub 2018 Jun 27.

  PMID: 30009789 BACKGROUND

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jason L Dragoo, MD

CONTACT

303-724-1055; J.DRAGOO@CUANSCHUTZ.EDU

Inverness Clinical Trials

CONTACT

Inverness.clinicaltrials@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (3)