ClinicalTrials.gg
CompletedNCT05112679OPORPUpdated Nov 25, 2025Results posted

Limb Health and Socket Pressure in Response to Powered Ankle Protheses

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

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pressure Ulcer, Ankle
  • Prosthesis User
  • Prosthesis Durability
  • Mobility Limitation
  • Skin Wound
  • Amputation; Traumatic, Foot
  • Amputation
  • Limb Deficiencies
03

In context

Pressure Ulcer

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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
  • Unilateral transtibial amputees
  • Must be able to ambulate without any assistive devices
  • Subjects must be able to follow directions and give on their own

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Proprio Foot

    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

  • Experimental
    Empower foot

    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

Interventions

  • DevicePROPRIO 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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 4 weeks

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 4 weeks

07

Results

Posted Nov 12, 2025

Participant flow

Participant flow — Overall Study
MilestoneProprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio Foot
Started33
Completed33
Not completed00

Outcome measures

PrimaryPowered 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
Reported as:
Mean · kPa/kg
Powered Transtibial Prosthesis on Socket Pressure
kPa/kgProprio FootEmpower Ankle
Powered Transtibial Prosthesis on Socket Pressure0.58 ± 0.010.25 ± 0.03
Statistical analysis
  • Proprio Foot vs Empower Ankle · Wilcoxon (Mann-Whitney) · p = 0.009 · Mean difference (final values): 0.007
SecondaryChange 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
Reported as:
Mean · Perfusion Units (PU)
Change in Skin Perfusion
Perfusion Units (PU)Proprio FootEmpower Ankle
Change in Skin Perfusion1.1 ± 0.750.8 ± 0.7
SecondaryTransepidermal 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
Reported as:
Mean · g/m^2 x h
Transepidermal Water Loss (TEWL)
g/m^2 x hProprio FootEmpower Ankle
Transepidermal Water Loss (TEWL)2.0 ± 0.610.8 ± 0.21

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Proprio Foot0/6 (0%)0/6 (0%)0/6 (0%)
Empower Ankle0/6 (0%)0/6 (0%)0/6 (0%)

Baseline characteristics

all participants that have completed the study

Age, Categorical
Age, Categorical(Participants)Proprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
<=18 years000
Between 18 and 65 years336
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Proprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
Female000
Male336
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Proprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American101
White235
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Proprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
United States336
participants completed the study visits
participants completed the study visits(Participants)Proprio Foot, Then Empower AnkleEmpower Ankle, Then Proprio FootTotal
Count of participants336
08

Study locations

1 site
  • Indiana University Health Methodist Hospital
    Indianapolis, Indiana 46228, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05112679
Lead sponsor
Indiana University
Collaborators
University of Notre Dame, United States Department of Defense
Responsible party
Dr. Sashwati Roy (Professor of Surgery, Indiana University) — Principal investigator
First posted
Nov 9, 2021
Start date
Nov 15, 2021
Primary completion
Jul 19, 2023
Completion
Jul 19, 2023
Results posted
Nov 12, 2025
Last update
Nov 25, 2025

Study contacts

Sashwati Roy, PhD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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