Lower Extremity Musculoskeletal InjuryNCT05608824
Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using SWE and MFI
A study testing Shear wave elastography and microvascular flow imaging. in people with Lower Extremity Musculoskeletal Injury, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
Primary Objective: To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Lower Extremity Musculoskeletal Injury
- What is being tested?
- Shear wave elastography and microvascular flow imaging.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 - 89 years;
- Able to sign an informed consent document;
- Suspected MSK injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle).
Who cannot join
- Prior fasciotomy of same limb;
- Hemodialysis grafts of involved extremity;
- Extremity wounds preventing ultrasound imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Oregon
Eugene, Oregon, 97403
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging
Primary Objective:
To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment.
Read more
Secondary Objective:
To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI.
Methodology:
Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
- Conditions
- Lower Extremity Musculoskeletal Injury
- Being tested
- Shear wave elastography and microvascular flow imaging.
- Keywords
- Ultrasound, Shear wave elastography, Microvascular flow imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear wave elastography and microvascular flow imaging.Device
Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal injury | Experimental | Shear wave elastography and microvascular flow imaging. Receives: Device: Shear wave elastography and microvascular flow imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
kPa
Tissue stiffness measured by shear wave elastography
Measured: Within 48 hours
kPa
Tissue stiffness measured by shear wave elastography
Measured: 5 days post injury (+/- 2 days)
kPa
Tissue stiffness measured by shear wave elastography
Measured: 6 weeks post injury (+/- 1 week)
kPa
Tissue stiffness measured by shear wave elastography
Measured: 12 weeks post injury (+/- 1 week)
kPa
Tissue stiffness measured by shear wave elastography
Measured: 24 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Measured: Within 48 hours
Presence of blood flow
Measured by microvascular flow imaging
Measured: 5 days post injury (+/- 2 days)
Presence of blood flow
Measured by microvascular flow imaging
Measured: 6 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Measured: 12 weeks post injury (+/- 1 week)
Presence of blood flow
Measured by microvascular flow imaging
Measured: 24 weeks post injury (+/- 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2023
- Primary completion28 Feb 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity Musculoskeletal InjuryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oregon
- Responsible party
- Principal investigator, Kenton W. Gregory, Oregon Health and Science University
- Investigators
- Kenton Gregory, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608824
- Sponsor's protocol ID
- 00000608
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010 Spring;19(1):2-7.
PubMed 20370999Kelly JF, Ritenour AE, McLaughlin DF, Bagg KA, Apodaca AN, Mallak CT, Pearse L, Lawnick MM, Champion HR, Wade CE, Holcomb JB. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008 Feb;64(2 Suppl):S21-6; discussion S26-7. doi: 10.1097/TA.0b013e318160b9fb.
PubMed 18376168Mauser N, Gissel H, Henderson C, Hao J, Hak D, Mauffrey C. Acute lower-leg compartment syndrome. Orthopedics. 2013 Aug;36(8):619-24. doi: 10.3928/01477447-20130724-07.
PubMed 23937740Ritenour AE, Dorlac WC, Fang R, Woods T, Jenkins DH, Flaherty SF, Wade CE, Holcomb JB. Complications after fasciotomy revision and delayed compartment release in combat patients. J Trauma. 2008 Feb;64(2 Suppl):S153-61; discussion S161-2. doi: 10.1097/TA.0b013e3181607750.
PubMed 18376159Ritenour AE, Blackbourne LH, Kelly JF, McLaughlin DF, Pearse LA, Holcomb JB, Wade CE. Incidence of primary blast injury in US military overseas contingency operations: a retrospective study. Ann Surg. 2010 Jun;251(6):1140-4. doi: 10.1097/SLA.0b013e3181e01270.
PubMed 20485126Rush RM Jr, Beekley AC, Puttler EG, Kjorstad RJ. The mangled extremity. Curr Probl Surg. 2009 Nov;46(11):851-926. doi: 10.1067/j.cpsurg.2009.05.003. No abstract available.
PubMed 19804853Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
PubMed 25543232Kragh JF Jr, Wade CE, Baer DG, Jones JA, Walters TJ, Hsu JR, Wenke JC, Blackbourne LH, Holcomb JB. Fasciotomy rates in operations enduring freedom and iraqi freedom: association with injury severity and tourniquet use. J Orthop Trauma. 2011 Mar;25(3):134-9. doi: 10.1097/BOT.0b013e3181e52333.
PubMed 21321506McMillan TE, Gardner WT, Schmidt AH, Johnstone AJ. Diagnosing acute compartment syndrome-where have we got to? Int Orthop. 2019 Nov;43(11):2429-2435. doi: 10.1007/s00264-019-04386-y. Epub 2019 Aug 29.
PubMed 31468110Brandenburg JE, Eby SF, Song P, Zhao H, Landry BW, Kingsley-Berg S, Bamlet WR, Chen S, Sieck GC, An KN. Feasibility and reliability of quantifying passive muscle stiffness in young children by using shear wave ultrasound elastography. J Ultrasound Med. 2015 Apr;34(4):663-70. doi: 10.7863/ultra.34.4.663.
PubMed 25792582Lacourpaille L, Hug F, Bouillard K, Hogrel JY, Nordez A. Supersonic shear imaging provides a reliable measurement of resting muscle shear elastic modulus. Physiol Meas. 2012 Mar;33(3):N19-28. doi: 10.1088/0967-3334/33/3/N19. Epub 2012 Feb 28.
PubMed 22370174Nightingale KR, Palmeri ML, Nightingale RW, Trahey GE. On the feasibility of remote palpation using acoustic radiation force. J Acoust Soc Am. 2001 Jul;110(1):625-34. doi: 10.1121/1.1378344.
PubMed 11508987Ganesan S, Man CS, Lai-Fook SJ. Generation and detection of lung stress waves from the chest surface. Respir Physiol. 1997 Oct;110(1):19-32. doi: 10.1016/s0034-5687(97)00065-0.
PubMed 9361149Catheline S, Thomas JL, Wu F, Fink MA. Diffraction field of a low frequency vibrator in soft tissues using transient elastography. IEEE Trans Ultrason Ferroelectr Freq Control. 1999;46(4):1013-9. doi: 10.1109/58.775668.
PubMed 18238506Sarvazyan AP, Rudenko OV, Swanson SD, Fowlkes JB, Emelianov SY. Shear wave elasticity imaging: a new ultrasonic technology of medical diagnostics. Ultrasound Med Biol. 1998 Nov;24(9):1419-35. doi: 10.1016/s0301-5629(98)00110-0.
PubMed 10385964
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lower Extremity Athletic Injuries and Response to Treatment Using Shear Wave Elastography and Micro-vascular Flow Imaging
- ClinicalTrials.gov ID
- NCT05608824
- Acronym / sponsor ID
- 00000608
- Conditions
- Lower Extremity Musculoskeletal Injury
- Keywords
- Ultrasound, Shear wave elastography, Microvascular flow imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Oregon
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Nov 2022 (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.
Primary Objective:
To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment.
Secondary Objective:
To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI.
Methodology:
Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal injury | Experimental | Device: Shear wave elastography and microvascular flow imaging.Shear wave elastography and microvascular flow imaging. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects age 18 - 89 years;
- Able to sign an informed consent document;
- Suspected MSK injury of the lower extremity (i.e. hamstring injuries and soft tissue injuries involving the ankle).
Key exclusion criteria (3 listed)
- Prior fasciotomy of same limb;
- Hemodialysis grafts of involved extremity;
- Extremity wounds preventing ultrasound imaging.
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 |
|---|---|---|
| Shear wave elastography and microvascular flow imaging.Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity. | Device | Musculoskeletal injury |
Primary outcome
kPa
Time frame: Within 48 hours
Tissue stiffness measured by shear wave elastography
kPa
Time frame: 5 days post injury (+/- 2 days)
Tissue stiffness measured by shear wave elastography
kPa
Time frame: 6 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
kPa
Time frame: 12 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
kPa
Time frame: 24 weeks post injury (+/- 1 week)
Tissue stiffness measured by shear wave elastography
Presence of blood flow
Time frame: Within 48 hours
Measured by microvascular flow imaging
Presence of blood flow
Time frame: 5 days post injury (+/- 2 days)
Measured by microvascular flow imaging
Presence of blood flow
Time frame: 6 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Presence of blood flow
Time frame: 12 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Presence of blood flow
Time frame: 24 weeks post injury (+/- 1 week)
Measured by microvascular flow imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 20370999Belmont PJ, Schoenfeld AJ, Goodman G. Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv. 2010 Spring;19(1):2-7.
- Background: PubMed 18376168Kelly JF, Ritenour AE, McLaughlin DF, Bagg KA, Apodaca AN, Mallak CT, Pearse L, Lawnick MM, Champion HR, Wade CE, Holcomb JB. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008 Feb;64(2 Suppl):S21-6; discussion S26-7. doi: 10.1097/TA.0b013e318160b9fb.
- Background: PubMed 23937740Mauser N, Gissel H, Henderson C, Hao J, Hak D, Mauffrey C. Acute lower-leg compartment syndrome. Orthopedics. 2013 Aug;36(8):619-24. doi: 10.3928/01477447-20130724-07.
- Background: PubMed 18376159Ritenour AE, Dorlac WC, Fang R, Woods T, Jenkins DH, Flaherty SF, Wade CE, Holcomb JB. Complications after fasciotomy revision and delayed compartment release in combat patients. J Trauma. 2008 Feb;64(2 Suppl):S153-61; discussion S161-2. doi: 10.1097/TA.0b013e3181607750.
- Background: PubMed 20485126Ritenour AE, Blackbourne LH, Kelly JF, McLaughlin DF, Pearse LA, Holcomb JB, Wade CE. Incidence of primary blast injury in US military overseas contingency operations: a retrospective study. Ann Surg. 2010 Jun;251(6):1140-4. doi: 10.1097/SLA.0b013e3181e01270.
- Background: PubMed 19804853Rush RM Jr, Beekley AC, Puttler EG, Kjorstad RJ. The mangled extremity. Curr Probl Surg. 2009 Nov;46(11):851-926. doi: 10.1067/j.cpsurg.2009.05.003. No abstract available.
- Background: PubMed 25543232Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
- Background: PubMed 21321506Kragh JF Jr, Wade CE, Baer DG, Jones JA, Walters TJ, Hsu JR, Wenke JC, Blackbourne LH, Holcomb JB. Fasciotomy rates in operations enduring freedom and iraqi freedom: association with injury severity and tourniquet use. J Orthop Trauma. 2011 Mar;25(3):134-9. doi: 10.1097/BOT.0b013e3181e52333.
- Background: PubMed 31468110McMillan TE, Gardner WT, Schmidt AH, Johnstone AJ. Diagnosing acute compartment syndrome-where have we got to? Int Orthop. 2019 Nov;43(11):2429-2435. doi: 10.1007/s00264-019-04386-y. Epub 2019 Aug 29.
- Background: PubMed 25792582Brandenburg JE, Eby SF, Song P, Zhao H, Landry BW, Kingsley-Berg S, Bamlet WR, Chen S, Sieck GC, An KN. Feasibility and reliability of quantifying passive muscle stiffness in young children by using shear wave ultrasound elastography. J Ultrasound Med. 2015 Apr;34(4):663-70. doi: 10.7863/ultra.34.4.663.
- Background: PubMed 22370174Lacourpaille L, Hug F, Bouillard K, Hogrel JY, Nordez A. Supersonic shear imaging provides a reliable measurement of resting muscle shear elastic modulus. Physiol Meas. 2012 Mar;33(3):N19-28. doi: 10.1088/0967-3334/33/3/N19. Epub 2012 Feb 28.
- Background: PubMed 11508987Nightingale KR, Palmeri ML, Nightingale RW, Trahey GE. On the feasibility of remote palpation using acoustic radiation force. J Acoust Soc Am. 2001 Jul;110(1):625-34. doi: 10.1121/1.1378344.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kenton Gregory, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear wave elastography and microvascular flow imaging. in people with Lower Extremity Musculoskeletal Injury, run by Oregon Health and Science University at 2 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kPa (time frame: Within 48 hours). The study lists 10 primary outcomes in all. 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 NCT05608824, which also lists 31 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 7 Apr 2026.