Blood Flow Restriction Therapy in Achilles Injury

NCT ID: NCT04104126

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Achilles Injuries Tendon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Standard of Care Physical Therapy

Patients with Achilles injury are prescribed PT for their treatment, therefore physical therapy is a standard of care treatment for patients with tendon pathology.

Group Type ACTIVE_COMPARATOR

Standard of Care Physical Therapy

Intervention Type OTHER

Will receive standard of care physical therapy

Blood flow restriction (BFR) therapy

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.

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type 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.

Interventions

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Standard of Care Physical Therapy

Will receive standard of care physical therapy

Intervention Type OTHER

Blood flow restriction

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillem Gonzalez-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Larry Chen

Role: CONTACT

(317)847-1784

Michael Moore

Role: CONTACT

347-554-0183

Facility Contacts

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Zachary Li

Role: primary

317-517-0426

Other Identifiers

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s19-01244

Identifier Type: -

Identifier Source: org_study_id

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