Recruiting

Blood Flow Restriction

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06254794

Conditions

Achilles Tendon Rupture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Physical therapy

Study Details

Brief summary:

The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.

Conditions

Achilles Tendon Rupture

Study ID

NCT06254794

Start date

Nov 13, 2018

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Achilles Rupture confirmed by MRI or Thompson Test
  • Adult
  • Receiving Percutaneous Achilles Repair System (PARS) or open repair
  • Proposed PT with Methodist Location

Exclusion Criteria:

  • Obesity (BMI>35)
  • Diabetes
  • Cardiovascular, renal, liver or pulmonary disease
  • Active infections
  • Cancer (current or treated within the past 2 years) or coagulation disorder
  • Physically unable to participate in the intervention
  • Unable to complete a minimum of 85% of the assigned rehabilitation sessions
  • Less than 18 years of age
  • Pregnant

Study Design

Enrollment

19 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood flow restriction group

The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises.

other: Standard of Care (control) group

The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch.

Interventions

Blood flow restriction with Delfi Personalized Tourniquet System (PTS)

Standard of care physical therapy exercises with the use of the Delfi PTS cuff

Physical therapy

Standard of care physical therapy exercises

Primary outcome measure

  • Muscle mass preservation [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]
  • Bone density preservation [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]
  • Improve patient reported outcomes (Physical activity) [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]
  • Improve patient reported outcomes (Pain) [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]
  • Improve patient reported outcomes (Achilles tendon survey) [ Time Frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op ]
  • Change in range of motion [ Time Frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16. ]
  • Change in single heel raise repetitions [ Time Frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16. ]

Central Contacts and Locations

Central contacts

Haley Goble

713.441.3930hmgoble@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Haley M Goble, MHA

7134413930hmgoble@houstonmethodist.org

Principal Investigator:

Patrick C McCulloch, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • achilles tendon rupture
  • blood flow restriction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-09-04.