NCT06496035 Blood Flow Restriction Training in Patients With Lower Extremity Fractures
| NCT ID | NCT06496035 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Denver Health and Hospital Authority |
| Condition | Tibial Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-11-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. The study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.
Eligibility Criteria
Inclusion Criteria: * Adult with closed tibial shaft fracture * Ability to begin physical therapy treatment within 2 weeks post-operatively Exclusion Criteria: * History of osteoporosis or osteopenia * Impaired circulation in the limb * Active deep vein thrombosis * Clotting disorders or other elevated risk of embolism * Sickle cell anemia * Infection in extremity * Renal compromise * Severe uncontrolled hypertension (SBP\>180) * Lymphedema * Under age 18 * Pregnancy * Prisoner
Contact & Investigator
Megan E Smith, PT, DPT
PRINCIPAL INVESTIGATOR
Denver Health
Frequently Asked Questions
Who can join the NCT06496035 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Tibial Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06496035 currently recruiting?
Yes, NCT06496035 is actively recruiting participants. Contact the research team at megan.smith@dhha.org for enrollment information.
Where is the NCT06496035 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT06496035 clinical trial?
NCT06496035 is sponsored by Denver Health and Hospital Authority. The principal investigator is Megan E Smith, PT, DPT at Denver Health. The trial plans to enroll 40 participants.