Lower Limb Amputation Below Knee (Injury)NCT04787640
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
A study testing Nike Sport Sole in people with Lower Limb Amputation Below Knee (Injury), run by Össur Iceland ehf.
Trial summary
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Nike Sport Sole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 3 Feb 2021
- 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
- 50Kg< body weight < 116Kg
- K-level: K3 and K4
- Amputation level: Unilateral, bilateral, Trans-tibial, trans-femoral
- Currently using running prosthesis with the option to connect to the components the investigational device is compatible to
- Minimum build height: Distance from ground to socket adapter needs to be 318 mm or more.
- Comfortable and stable socket fit
- Willing and able to participate in the study and follow the protocol
Who cannot join
- 50Kg> body weight > 116Kg
- Users with socket problems
- Users with cognitive impairment
- Younger than 18 years old
About this study
Official title: Wear and Tear Evaluation of New Nike Sport Sole, an Accessory Attachable and Detachable to the Running Prosthesis Cheetah Xceed
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. They all have similar design features such as a C-shaped spring carbon fiber foot plate that absorbs and returns energy when load is applied deflecting the carbon. In order to accommodate the running pattern which does not show a double stance phase as compared to walking, the Running Specific products do not feature a heel spring but directly load the C-shape spring at initial contact. The Running Specific Feet are usually equipped with additional accessory parts such as a traction sole or spike pad for smoother and more natural rollover.
The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
Read the detailed description
The primary objective of this study is to evaluate the observed wear and tear of the new Nike Sport Sole after 6-8 weeks usage among other usability aspects compared to subjects current prescribed running prosthesis/sole combination.
- Recruitment Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point, they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered.
Potential risk of participating in the investigation will be explained to the subject at this point to the candidate for enrolment.
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
ii) Test procedure There are two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
Visit 1. Prior to fitting the investigational device, the subjects will be asked to provide feedback on their current prescribed running prosthesis, by filling in a set of questionnaires, run outside, both on level and rolling terrain and attach and detach the sole to blade. Investigators will record name and category of their current device and type of sole used. Picture will be taken of the current device from side and front.
The users will then be fitted to the investigational device within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Subjects will be asked to provide feedback on the investigational device by filling in same sets of questionnaires and perform the same tasks. Users will be handed a journal to fill out information regarding their sport activities during the next 6-8 weeks while using the investigational device.
Visit 2. The second event will take place 6-8 weeks later. When the subjects arrive at the clinic, investigators will take pictures of the investigational device (and IDs) from side and front, review subjects journal and the wear and tear of the investigational device will be evaluated. Alignment will also be reviewed. Subjects will be asked to once again, fill in the same sets of questionnaires as during the first visit and perform the same set of tasks. At last, subjects will be re-fitted to their previous prescribed device, same tasks and questionnaires will once again be repeated.
- Being tested
- Nike Sport Sole
- Keywords
- prosthesis, running, nike sole, cheetah
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nike Sport SoleDevice
The Nike Sport Sole comes in two different versions, Nike traction sole and Nike spike pad. Both versions are easily attachable and detachable to the foot blade of the running specific prosthetic foot, Cheetah® Xceed.
Both sole versions consist of a rubber traction sole with a soft foam core. The Nike spike pad consists of a spike sole with a soft foam core and should be used when running on tartan track. Both sole versions are attached in the same way to the carbon foot blade. The devices slide onto the carbon foot blade and are connected by pulling a strap of the sole over an attachment piece (medallion) that is connected to the foot blade. Additionally, there are attachment clips on the side clamp on the foot blade.
| Study group | Role | What they receive |
|---|---|---|
| Wear and tear of new Nike Sport Sole | Experimental | The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects. Receives: Device: Nike Sport Sole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wear and Tear of the Nike Sport Sole
Visual inspection of wear and tear of the Nike Sport Sole using a custom Wear/Tear Scoring Sheet. The Wear/Tear Scoring Sheet is an ordinal rating scale designed to evaluate the physical condition and durability of different regions of the sole-mounted prosthetic product after use. Each item was rated on a 5-point scale (1 = severe wear/damage, 5 = no or minimal wear/damage). Higher scores indicate better product condition and less wear, while lower scores indicate greater wear or damage. Item scores were summed across all assessed regions, divided by the maximum possible total score, and multiplied by 100 to obtain a percentage score. Higher percentages indicate less wear and better overall product condition.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start20 Feb 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
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 Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787640
- Sponsor's protocol ID
- CIP2020010830
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2020
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
- Wear and Tear Evaluation of New Nike Sport Sole, an Accessory Attachable and Detachable to the Running Prosthesis Cheetah Xceed
- ClinicalTrials.gov ID
- NCT04787640
- Acronym / sponsor ID
- CIP2020010830
- Keywords
- prosthesis, running, nike sole, cheetah
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging. They all have similar design features such as a C-shaped spring carbon fiber foot plate that absorbs and returns energy when load is applied deflecting the carbon. In order to accommodate the running pattern which does not show a double stance phase as compared to walking, the Running Specific products do not feature a heel spring but directly load the C-shape spring at initial contact. The Running Specific Feet are usually equipped with additional accessory parts such as a traction sole or spike pad for smoother and more natural rollover.
The investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects.
Detailed description
The primary objective of this study is to evaluate the observed wear and tear of the new Nike Sport Sole after 6-8 weeks usage among other usability aspects compared to subjects current prescribed running prosthesis/sole combination.
- Recruitment Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point, they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered.
Potential risk of participating in the investigation will be explained to the subject at this point to the candidate for enrolment.
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
ii) Test procedure There are two scheduled study events. At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
Visit 1. Prior to fitting the investigational device, the subjects will be asked to provide feedback on their current prescribed running prosthesis, by filling in a set of questionnaires, run outside, both on level and rolling terrain and attach and detach the sole to blade. Investigators will record name and category of their current device and type of sole used. Picture will be taken of the current device from side and front.
The users will then be fitted to the investigational device within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Subjects will be asked to provide feedback on the investigational device by filling in same sets of questionnaires and perform the same tasks. Users will be handed a journal to fill out information regarding their sport activities during the next 6-8 weeks while using the investigational device.
Visit 2. The second event will take place 6-8 weeks later. When the subjects arrive at the clinic, investigators will take pictures of the investigational device (and IDs) from side and front, review subjects journal and the wear and tear of the investigational device will be evaluated. Alignment will also be reviewed. Subjects will be asked to once again, fill in the same sets of questionnaires as during the first visit and perform the same set of tasks. At last, subjects will be re-fitted to their previous prescribed device, same tasks and questionnaires will once again be repeated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wear and tear of new Nike Sport Sole | Experimental | Device: Nike Sport SoleThe investigational device, the Nike Sport Sole, is an accessory for the Cheetah Xceed running prosthetic foot. Cheetah Xceed has already been placed on market and bears a CE mark, but the Nike Sport Sole is an upgraded Nike Sole design and the objective of this clinical investigation is to evaluate the observed wear and tear of the soles after 6-8 week usage among other usability aspects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50Kg< body weight < 116Kg
- K-level: K3 and K4
- Amputation level: Unilateral, bilateral, Trans-tibial, trans-femoral
- Currently using running prosthesis with the option to connect to the components the investigational device is compatible to
- Minimum build height: Distance from ground to socket adapter needs to be 318 mm or more.
Key exclusion criteria (4 listed)
- 50Kg> body weight > 116Kg
- Users with socket problems
- Users with cognitive impairment
- Younger than 18 years old
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 |
|---|---|---|
| Nike Sport SoleThe Nike Sport Sole comes in two different versions, Nike traction sole and Nike spike pad. Both versions are easily attachable and detachable to the foot blade of the running specific prosthetic foot, Cheetah® Xceed. Both sole versions consist of a rubber traction sole with a soft foam core. The Nike spike pad consists of a spike sole with a soft foam core and should be used when running on tartan track. Both sole versions are attached in the same way to the carbon foot blade. The devices slide onto the carbon foot blade and are connected by pulling a strap of the sole over an attachment piece (medallion) that is connected to the foot blade. Additionally, there are attachment clips on the side clamp on the foot blade. | Device | Wear and tear of new Nike Sport Sole |
Primary outcome
Percentage of Wear and Tear of the Nike Sport Sole
Time frame: 6-8 weeks
Visual inspection of wear and tear of the Nike Sport Sole using a custom Wear/Tear Scoring Sheet. The Wear/Tear Scoring Sheet is an ordinal rating scale designed to evaluate the physical condition and durability of different regions of the sole-mounted prosthetic product after use. Each item was rated on a 5-point scale (1 = severe wear/damage, 5 = no or minimal wear/damage). Higher scores indicate better product condition and less wear, while lower scores indicate greater wear or damage. Item scores were summed across all assessed regions, divided by the maximum possible total score, and multiplied by 100 to obtain a percentage score. Higher percentages indicate less wear and better overall product condition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nike Sport Sole in people with Lower Limb Amputation Below Knee (Injury), run by Össur Iceland ehf.
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 7 inclusion and 4 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 Sep 2026). 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?
Percentage of Wear and Tear of the Nike Sport Sole (time frame: 6-8 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 4 Sep 2026.