Pressure Ulcer, AnkleOPORPNCT05112679
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
A study testing PROPRIO FOOT® by Ossur & Empower ankle by Ottobock in people with Pressure Ulcer, Ankle and Prosthesis User, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability
- What is being tested?
- PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 18 and above
- Weight ≤ 280 lb
- Ambulate at a K3 level or higher-level determined from patient EHR
- At least 3 months post-amputation per physician discretion
- Residual limb length greater than 4.5 inches
- Use of a passive prosthesis
Show all 9Show fewer
- Unilateral transtibial amputees
- Must be able to ambulate without any assistive devices
- Subjects must be able to follow directions and give informed consent on their own
Who cannot join
- Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
- Other amputees
- Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant in the near future
- Individuals diagnosed with renal failure
- Participants unwilling to wear a cloth face covering for the duration of each visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46228
About this study
Official title: Limb Health and Socket Pressure in Response to Powered Ankle Prostheses
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.
Read the detailed description
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.
- Conditions
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation, Skin Wound, Amputation; Traumatic, Foot
- Being tested
- PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
- Medical subject headings
- Pressure Ulcer, Prosthesis Failure, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROPRIO FOOT® by Ossur & Empower ankle by OttobockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Proprio Foot | Experimental | each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio Receives: Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock |
| Empower foot | Experimental | ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio Receives: Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
Transepidermal Water Loss (TEWL)
Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Nov 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure Ulcer, AnkleStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Notre Dame, United States Department of Defense
- Responsible party
- Principal investigator, Dr. Sashwati Roy, Indiana University
- Investigators
- Sashwati Roy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112679
- Sponsor's protocol ID
- 12350
- Acronym
- OPORP
- Status last verified
- Nov 2025
- First submitted
- 13 Aug 2021
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limb Health and Socket Pressure in Response to Powered Ankle Prostheses
- ClinicalTrials.gov ID
- NCT05112679
- Acronym / sponsor ID
- OPORP / 12350
- Conditions
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation, Skin Wound, Amputation; Traumatic, Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Notre Dame, United States Department of Defense
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprio Foot | Experimental | Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobockeach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio |
| Empower foot | Experimental | Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobockach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 18 and above
- Weight ≤ 280 lb
- Ambulate at a K3 level or higher-level determined from patient EHR
- At least 3 months post-amputation per physician discretion
- Residual limb length greater than 4.5 inches
Key exclusion criteria (6 listed)
- Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
- Other amputees
- Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant in the near future
- Individuals diagnosed with renal failure
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 |
|---|---|---|
| PROPRIO FOOT® by Ossur & Empower ankle by OttobockPROPRIO 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. | Device | Empower foot, Proprio Foot |
Primary outcome
Powered Transtibial Prosthesis on Socket Pressure
Time frame: 4 weeks
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
2 secondary outcomes
Change in Skin Perfusion
Time frame: 4 weeks
Transepidermal Water Loss (TEWL)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.
Related trials for Pressure Ulcer, Ankle
Not yet recruiting
Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle-Brachial Pressure Index in Patients With Diabetic Foot Ulcer
Diabetes Mellitus, Diabetic Foot Ulcer
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. This study is not recruiting at the moment.
Sashwati Roy, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROPRIO FOOT® by Ossur & Empower ankle by Ottobock in people with Pressure Ulcer, Ankle and Prosthesis User, run by Indiana University 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Powered Transtibial Prosthesis on Socket Pressure (time frame: 4 weeks). 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 25 Nov 2025.