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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT05112679
Study groupRoleWhat they receive
Proprio FootExperimentaleach 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 footExperimentalach 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted9 Nov 2021
  2. Study start15 Nov 2021
  3. Primary completion19 Jul 2023
  4. Study completion19 Jul 2023

Resources

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)
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
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.

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.

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