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NCT Number: NCT04104126

Blood Flow Restriction Therapy in Achilles Injury

Blood flow restriction (BFR) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. It is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. This prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of Achilles injuries.

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Key information

Conditions

Achilles Injuries Tendon

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10017, United States

Location status: Recruiting

Location contact

Guillem Gonzalez-Lomas, MD

PRINCIPAL_INVESTIGATOR

Zachary Li

CONTACT

[email protected]

317-517-0426

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Achilles Injury
  • Must be at least 18 years of age and younger than 65 years of age
  • Intention to receive physical therapy as standard of care

Exclusion criteria

  • Patients with intention to receive standard therapy and not the study therapy
  • Patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension
  • Younger than 18 years of age or older than 65
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Any patient considered a vulnerable subject

Treatment and study plan

Standard of care physical therapy

Other

Will receive standard of care physical therapy

Blood Flow Restriction

Other

Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed.

Primary outcomes

  1. efficacy of blood flow restriction therapy on patients with Achilles injury by measure pre and post blood flow restriction therapy measured by muscle strength

    Time frame: 12 Months

    Measure in increase of strength in the affected leg measured by Biodex.

  2. Measure of pain using Visual Analog Scale (VAS)

    Time frame: 12 Months

    Respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Chen

CONTACT

[email protected]

(317)847-1784

Michael Moore

CONTACT

[email protected]

347-554-0183

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2019
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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