Lower Extremity InjuryNCT07566039
Cohort Study of PPP Injections for Athletes With Muscle Injury
A study testing Platelet Poor Plasma (PPP) Injection in people with Lower Extremity Injury, run by University of Colorado, Denver at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Lower Extremity Injury
- What is being tested?
- Platelet Poor Plasma (PPP) Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Inverness Clinical Trials contact
United States3 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado | Steadman Hawkins Clinic Denver
Englewood, Colorado, 80112
Jason L Dragoo, MD, 720-872-4836, J.DRAGOO@CUANSCHUTZ.EDU
Inverness Clinical Trials, 720-872-4836, Inverness.clinicaltrials@cuanschutz.edu
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute 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.
- Conditions
- Lower Extremity Injury
- Being tested
- Platelet Poor Plasma (PPP) Injection
- Keywords
- Lower extremity injury, PPP injection, Platelet Poor Plasma injection, Athlete, muscle injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Poor Plasma (PPP) InjectionDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline MRI and 6-month follow-up MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity InjuryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of Iowa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566039
- Sponsor's protocol ID
- 22-1841
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 17972452Yilmaz 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.
PubMed 21138357Thierfelder 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.
PubMed 30771029Tchkonia 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.
PubMed 23454759Stevens 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.
PubMed 20051499Shahidi 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.
PubMed 28948378Setayesh 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.
PubMed 30343400Otrocka-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.
PubMed 30744624Mueller-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.
PubMed 23080315Miroshnychenko 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.
PubMed 28027451Malahias 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.
PubMed 30572281Liu 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.
PubMed 31309121Levine 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.
PubMed 10843118Lee 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.
PubMed 22496067Laberge 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.
PubMed 22404905
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Athletes Following an Injection of Platelet-Poor Plasma Into an Acute Muscle Injury
- ClinicalTrials.gov ID
- NCT07566039
- Acronym / sponsor ID
- 22-1841
- Conditions
- Lower Extremity Injury
- Keywords
- Lower extremity injury, PPP injection, Platelet Poor Plasma injection, Athlete, muscle injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Emory University, University of Iowa
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPP Injection Treated Arm | Experimental | Device: Platelet Poor Plasma (PPP) InjectionUS-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 Injection Arm | No intervention | –Standard of care pathway with US-guided aspiration of hematoma (if present) and physical therapy only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Poor Plasma (PPP) InjectionUS-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 | PPP Injection Treated Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 17972452Zavadil 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.
- Background: PubMed 21138357Yilmaz 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.
- Background: PubMed 30771029Thierfelder 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.
- Background: PubMed 23454759Tchkonia 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.
- Background: PubMed 20051499Stevens 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.
- Background: PubMed 28948378Shahidi 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.
- Background: PubMed 30343400Setayesh 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.
- Background: PubMed 30744624Otrocka-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.
- Background: PubMed 23080315Mueller-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.
- Background: PubMed 28027451Miroshnychenko 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.
- Background: PubMed 30572281Malahias 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.
- Background: PubMed 31309121Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inverness Clinical Trials contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Poor Plasma (PPP) Injection in people with Lower Extremity Injury, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason L Dragoo, MD (303-724-1055, J.DRAGOO@CUANSCHUTZ.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07566039, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.