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Search / Trial NCT06496035

Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Launched by DENVER HEALTH AND HOSPITAL AUTHORITY · Jul 3, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients with tibial fractures, which are breaks in the shinbone. Researchers want to find out if using a special device that restricts blood flow during light exercises can improve muscle strength, size, and healing compared to regular exercises without the device. The goal is to see which method helps patients recover better and return to their normal activities more quickly.

To participate in this study, you need to be an adult who has a closed tibial shaft fracture and can start physical therapy within two weeks after surgery. Unfortunately, if you have certain conditions like osteoporosis, circulation problems, or are pregnant, you won't be eligible. If you join the trial, you’ll be assigned to one of two groups: one will use the blood flow restriction device while exercising, and the other will do the exercises without it. The study is not yet recruiting participants, but it aims to provide valuable information on improving recovery for patients with similar injuries.

Gender

ALL

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

About Denver Health And Hospital Authority

Denver Health and Hospital Authority is a leading integrated healthcare system dedicated to providing high-quality medical care and advancing public health through innovative research and clinical trials. As a prominent academic medical center, Denver Health combines comprehensive patient services with a commitment to medical education and community outreach. The organization plays a vital role in advancing healthcare solutions by conducting rigorous clinical trials that aim to improve patient outcomes and address pressing health challenges. With a focus on collaboration and ethical standards, Denver Health is dedicated to enhancing the understanding of disease and treatment efficacy through its robust research initiatives.

Locations

Denver, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Megan E Smith, PT, DPT

Principal Investigator

Denver Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported