An interventional study of PROPRIO FOOT® by Ossur & Empower ankle by Ottobock in Pressure Ulcer, Ankle, Prosthesis User and Prosthesis Durability, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
Some estimates suggest that by 2050, as many as 3.6 million people in the United States will be living with limb loss, and at least 60% of them will have had at least a foot removed For military personnel, combat-related amputations remain one of the most common major disabling war-related injuries from modern armed conflict. Technological advancements in active prosthetic devices for individuals with transtibial amputation offer the potential for superior function in key areas that could lead to higher rates of RTD and improved quality of life. Currently intended primarily for individuals with a K-level of 3 or 4, active transtibial prostheses that provide controlled plantar/dorsiflexion in either swing (microprocessor-controlled prostheses) or late stance (prostheses with powered propulsion) are likely to become the gold standard in the future as technology continues to improve Indeed, users of these types of prostheses have higher mobility than those using any of the other four categories of prosthetic ankle-foot mechanisms for unlimited community ambulators. Note that a major insurer has recently declared microprocessor-controlled ankle-foot prostheses medically necessary for members whose functional level is 3 or above.The PROPRIO FOOT® by Ossur, is a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. This added ankle control of these devices reduces the risk of falls by increasing toe clearance supports more natural standing posture on slopes and improves stair and slope ascent/descent capability by adapting to the change in terrain. On stairs, the PROPRIO FOOT® has been shown to improve affected leg knee kinematics (increased knee flexion) and kinetics (increased knee moment) instance. These improvements also contributed to higher interlimb symmetry reduced energetic cost of slope ascent and higher Amputee Mobility Predictor with a Prosthesis (AMPPRO) scores . Although the ankle of the PROPRIO FOOT® can be controlled in swing, the device does not have adequate power to provide an active propulsion instance. The Empower ankle by Ottobock is a powered prosthesis that provides active propulsion in late stance to mimic the positive work performed by the ankle plantar flexors in push-off. The Empower has been shown to improve affected leg kinematics (increased ankle range of motion and reduced knee flexion) on smooth flat ground ramp ascent and gravel]. In terms of kinetics, the Empower likewise results in increased ankle power on level ground stairs and ramps . Active prostheses like the PROPRIO FOOT® and Empower ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. As with all prosthetic components, though, these active devices are of little use if they induce pain and/or injury at the residual limb to the degree that the user will simply not wear them. The investigators will examine how optimal fit of lower limb prostheses can impact individuals comfort and/or reduce irritation.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio
Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio
Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.
Powered Transtibial Prosthesis on Socket Pressure
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
Time frame: 4 weeks
Change in Skin Perfusion
Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
Time frame: 4 weeks
Transepidermal Water Loss (TEWL)
Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
Time frame: 4 weeks
| Milestone | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
| kPa/kg | Proprio Foot | Empower Ankle |
|---|---|---|
| Powered Transtibial Prosthesis on Socket Pressure | 0.58 ± 0.01 | 0.25 ± 0.03 |
Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
| Perfusion Units (PU) | Proprio Foot | Empower Ankle |
|---|---|---|
| Change in Skin Perfusion | 1.1 ± 0.75 | 0.8 ± 0.7 |
Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
| g/m^2 x h | Proprio Foot | Empower Ankle |
|---|---|---|
| Transepidermal Water Loss (TEWL) | 2.0 ± 0.61 | 0.8 ± 0.21 |
Collected over period of all study visits from baseline (week 0) to final visit (week 8); each intervention was evaluated for four weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proprio Foot | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Empower Ankle | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
all participants that have completed the study
| Age, Categorical(Participants) | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 2 | 3 | 5 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
| participants completed the study visits(Participants) | Proprio Foot, Then Empower Ankle | Empower Ankle, Then Proprio Foot | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.
Supporting information: Statistical analysis plan, Informed consent form
Time frame: 6 months after completion
Access criteria: Email study contact
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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