NCT04149977 Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
| NCT ID | NCT04149977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Lower Limb Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-02-01 |
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 128 participants in total. It began in 2021-09-01 with a primary completion date of 2026-02-01.
⚠ 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
The primary objective of the study is to determine the efficacy of blood flow restriction therapy on patients with lower limb extensor injuries by measuring pre and post blood flow restriction therapy strength and muscle mass.
Eligibility Criteria
Inclusion Criteria: * Must be at least 18 years of age and younger than 65 years of age * ASA class I-II * Diagnosed with a lower limb extensor injury (quadriceps tendon rupture, patella tendon rupture, patella fracture) * Intention to receive physical therapy as standard of care Exclusion Criteria: * Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.) * Younger than 18 years of age or older than 65 * Any patient considered a vulnerable subject * Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension * Concomitant lower extremity traumatic injuries, delaying or precluding the subject's ability to participate in the therapy * Immobile or use of mobile assistive device prior to injury * No prior extensor injuries * Patients with Sickle cell anemia or venous thromboembolism * Patients with cancer or Lymphectomies * Patients with increased intracranial pressure * Patients with intention to receive standard therapy and not the study therapy
Contact & Investigator
Guillem Gonzales-Lomas, MD
PRINCIPAL INVESTIGATOR
NYU Langone
Frequently Asked Questions
Who can join the NCT04149977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lower Limb Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04149977 currently recruiting?
Yes, NCT04149977 is actively recruiting participants. Contact the research team at Samy.shelbaya@nyulangone.org for enrollment information.
Where is the NCT04149977 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04149977 clinical trial?
NCT04149977 is sponsored by NYU Langone Health. The principal investigator is Guillem Gonzales-Lomas, MD at NYU Langone. The trial plans to enroll 128 participants.