Achilles Tendon RuptureNCT06254794
Effect of BFR Rehab After Achilles Tendon Rupture
A study testing Blood flow restriction with Delfi Personalized Tourniquet System (PTS) and Physical therapy in people with Achilles Tendon Rupture, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Blood flow restriction with Delfi Personalized Tourniquet System (PTS) and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2018to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Achilles Rupture confirmed by MRI or Thompson Test
- Adult
- Receiving Percutaneous Achilles Repair System (PARS) or open repair
- Proposed PT with Methodist Location
Who cannot join
- 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
Show all 9Show fewer
- Unable to complete a minimum of 85% of the assigned rehabilitation sessions
- Less than 18 years of age
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Haley M Goble, MHA, 7134413930, hmgoble@houstonmethodist.org
Patrick C McCulloch, MD
About this study
Official title: Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
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.
Read the detailed description
The purpose of this research study is to determine if the use of Blood Flow Restriction, BFR, therapy in addition to standard physical therapy (PT) for post-Achilles tendon rupture reconstruction will decrease post-operative muscle atrophy (loss of muscle), increases dorsal and planar ankle flexion (range of motion), increase strength, and ultimately decrease return to play time for the BFR therapy group as compared to the control group.
Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Blood flow restriction with Delfi Personalized Tourniquet System (PTS), Physical therapy
- Keywords
- achilles tendon rupture, blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction with Delfi Personalized Tourniquet System (PTS)Device
Standard of care physical therapy exercises with the use of the Delfi PTS cuff
Physical therapyOther
Standard of care physical therapy exercises
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction group | Experimental | The study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises. Receives: Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS); Other: Physical therapy |
| Standard of Care (control) group | Other | The control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass preservation
Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).
Measured: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Bone density preservation
Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).
Measured: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Physical activity)
Digital RedCap survey tool sends Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function survey which consists of questions about their physical health and patient responds with Excellent, Very Good, Good, Fair or poor. Using healthmeasures.net, responses are converted to T-scores based on the general population. The highest the T-scores, the better physical health the patient has.
Measured: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Pain)
Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).
Measured: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Improve patient reported outcomes (Achilles tendon survey)
Digital RedCap survey tool sends Achilles Tendon Rupture Score (ATRS) survey. This survey asks 10 questions where the patient answers from 0=major limitation to 10=No limitations. High scores point to better physical activity.
Measured: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Change in range of motion
Physical therapy will do functional assessments including: leg squat depth, Y balance anterior, y balance posteromedial, y balance posterolateral and measure in centimeters (cm). The measurements will be taken at each physical therapy appointment and compared at the end of the study.
Measured: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Change in single heel raise repetitions
Physical therapy will count how many heel raises can be done at each timepoint.
Measured: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start13 Nov 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Delfi PTS device for BFR allows for a systematic and customized approach to BFR training in the clinic. This instrument provides a digital display of pressure, inflation time, and provides the user with an interface to control the tourniquet system. Pressure is monitored and regulated continuously to compensate for changing levels in the cuff during movement. Each cuff is specifically designed for the tapered contour of a body limb (arm or leg) and sized appropriately based on body region. These cuffs only work with the Delfi PTS device and allow for comfortable pressure application. Exercise will be performed with the cuff placed around the proximal limb and inflated through the duration of activity (\~5 minutes), then immediately deflated.
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254794
- Sponsor's protocol ID
- Pro00019305
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
- ClinicalTrials.gov ID
- NCT06254794
- Acronym / sponsor ID
- Pro00019305
- Conditions
- Achilles Tendon Rupture
- Keywords
- achilles tendon rupture, blood flow restriction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this research study is to determine if the use of Blood Flow Restriction, BFR, therapy in addition to standard physical therapy (PT) for post-Achilles tendon rupture reconstruction will decrease post-operative muscle atrophy (loss of muscle), increases dorsal and planar ankle flexion (range of motion), increase strength, and ultimately decrease return to play time for the BFR therapy group as compared to the control group.
Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Delfi PTS device for BFR allows for a systematic and customized approach to BFR training in the clinic. This instrument provides a digital display of pressure, inflation time, and provides the user with an interface to control the tourniquet system. Pressure is monitored and regulated continuously to compensate for changing levels in the cuff during movement. Each cuff is specifically designed for the tapered contour of a body limb (arm or leg) and sized appropriately based on body region. These cuffs only work with the Delfi PTS device and allow for comfortable pressure application. Exercise will be performed with the cuff placed around the proximal limb and inflated through the duration of activity (~5 minutes), then immediately deflated.
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction group | Experimental | Device: Blood flow restriction with Delfi Personalized Tourniquet System (PTS), Other: Physical therapyThe study group will undergo normal Achilles tendon rupture reconstruction rehab modified by use of a tourniquet for blood flow restriction during selected exercises. |
| Standard of Care (control) group | Other | Other: Physical therapyThe control group will undergo the normal Achilles tendon rupture reconstruction rehab protocol as determined by Drs. Varner and McCulloch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Achilles Rupture confirmed by MRI or Thompson Test
- Adult
- Receiving Percutaneous Achilles Repair System (PARS) or open repair
- Proposed PT with Methodist Location
Key exclusion criteria (9 listed)
- Obesity (BMI>35)
- Diabetes
- Cardiovascular, renal, liver or pulmonary disease
- Active infections
- Cancer (current or treated within the past 2 years) or coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction with Delfi Personalized Tourniquet System (PTS)Standard of care physical therapy exercises with the use of the Delfi PTS cuff | Device | Blood flow restriction group |
| Physical therapyStandard of care physical therapy exercises | Other | Blood flow restriction group, Standard of Care (control) group |
Primary outcome
Muscle mass preservation
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Lean mass for lower extremity measured in kilograms (kg) using Dual-Energy-Xray-Absorptiometry (DEXA).
Bone density preservation
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Bone mineral content measured in grams using Dual-Energy-Xray-Absorptiometry (DEXA).
Improve patient reported outcomes (Physical activity)
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Digital RedCap survey tool sends Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function survey which consists of questions about their physical health and patient responds with Excellent, Very Good, Good, Fair or poor. Using healthmeasures.net, responses are converted to T-scores based on the general population. The highest the T-scores, the better physical health the patient has.
Improve patient reported outcomes (Pain)
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Digital RedCap survey tool sends Pain Visual Analog Scale asking patients to rate their pain from 0 (no pain) to 100 (worst pain possible).
Improve patient reported outcomes (Achilles tendon survey)
Time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op
Digital RedCap survey tool sends Achilles Tendon Rupture Score (ATRS) survey. This survey asks 10 questions where the patient answers from 0=major limitation to 10=No limitations. High scores point to better physical activity.
Change in range of motion
Time frame: Starting 4 weeks post op, patient will go to physical therapy twice a week until week 16.
Physical therapy will do functional assessments including: leg squat depth, Y balance anterior, y balance posteromedial, y balance posterolateral and measure in centimeters (cm). The measurements will be taken at each physical therapy appointment and compared at the end of the study.
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.
Physical therapy will count how many heel raises can be done at each timepoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction with Delfi Personalized Tourniquet System (PTS) and Physical therapy in people with Achilles Tendon Rupture, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Goble (713.441.3930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass preservation (time frame: pre-op, 4 weeks post op, 8 weeks post op, 16 weeks post-op). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.