AmputationNCT05628064
1C70 Feasibility Study
A study testing 1C70 and Pro-Flex XC in people with Amputation, run by Otto Bock Healthcare Products GmbH at 6 sites in Germany.
Trial summary
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- 1C70 and Pro-Flex XC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 6 sitesGermany
- Study dates
- 24 Nov 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Person is at least 18 years old.
- Person is a unilateral transtibial amputee with stabilized residual limb.
- Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .
- Person has at least 6 months experience in walking with a prosthesis.
- Person is using an energy storage and return (ESR) foot as their primary everyday foot
- Person has a foot size between 22 and 30.
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- Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25).
- Person wears a prosthesis daily and ≥ 8 hours/day.
- Person is able to walk at least 500 m without having to make a break.
- Person is willing and able to independently provide informed consent.
- Person is willing to comply with study procedures.
Who cannot join
- Person is pregnant.
- Person is using a hydraulic foot as their primary everyday foot.
- Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.
- Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).
- Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).
- Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system).
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- Person is not available for study visits during planned study duration.
- Person is participating in another study or intends to participate in another study during this study´s duration.
- Person cannot personally provide their consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen (ZHT PFH)
Göttingen
John+Bamberg
Hanover
Pohlig Heidelberg
Heidelberg
UKM ProTec
Münster
Pohlig Nürnberg
Nuremberg
Pohlig Traunstein
Traunstein
About this study
Official title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.
- Conditions
- Amputation
- Being tested
- 1C70, Pro-Flex XC
- Keywords
- amputation, transtibial, prosthetic foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1C70Device
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Pro-Flex XCDevice
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects.
| Study group | Role | What they receive |
|---|---|---|
| 1C70 to Pro-Flex XC | Experimental | Transtibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC Receives: Device: 1C70; Device: Pro-Flex XC |
| Pro-Flex XC to 1C70 | Experimental | Transtibial amputees randomized to start with Pro-Flex XC and cross over to 1C70 Receives: Device: 1C70; Device: Pro-Flex XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for everyday foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Measured: 2 months after fitting with the last study feet
Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for comparator foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Measured: 2 months after fitting with the last study feet
Change in patient-perceived mobility (PLUS-M) compared to baseline
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Measured: Baseline measurement vs 2 months after fitting with 1C70
Change in patient-perceived mobility (PLUS-M) compared to the comparator foot
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Measured: 2 months after fitting with each of the study feet
Highest pain reported: 1C70 vs everyday foot
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the everyday foot.
Measured: Baseline measurement vs 2 months after fitting with 1C70
Highest pain reported: 1C70 vs comparator foot
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the coparator foot.
Measured: 2 months after fitting with each of the study feet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start24 Nov 2022
- Primary completion30 May 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over controlled trial
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628064
- Sponsor's protocol ID
- D000002112
- Other IDs
- CIV-22-08-040306
- Status last verified
- Jun 2025
- First submitted
- 16 Nov 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.
PubMed 29414988Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.
PubMed 39630588
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot
- ClinicalTrials.gov ID
- NCT05628064
- Acronym / sponsor ID
- D000002112
- Conditions
- Amputation
- Keywords
- amputation, transtibial, prosthetic foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Ottobock SE & Co. KGaA
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over controlled trial
| Arm | Type | Receives |
|---|---|---|
| 1C70 to Pro-Flex XC | Experimental | Device: 1C70, Device: Pro-Flex XCTranstibial amputees randomized to start with 1C70 and cross over to Pro-Flex XC |
| Pro-Flex XC to 1C70 | Experimental | Device: 1C70, Device: Pro-Flex XCTranstibial amputees randomized to start with Pro-Flex XC and cross over to 1C70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Person is at least 18 years old.
- Person is a unilateral transtibial amputee with stabilized residual limb.
- Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .
- Person has at least 6 months experience in walking with a prosthesis.
- Person is using an energy storage and return (ESR) foot as their primary everyday foot
Key exclusion criteria (9 listed)
- Person is pregnant.
- Person is using a hydraulic foot as their primary everyday foot.
- Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.
- Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).
- Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).
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 |
|---|---|---|
| 1C70Investigational energy storage and return prosthetic foot with using novel elastic elements. | Device | 1C70 to Pro-Flex XC, Pro-Flex XC to 1C70 |
| Pro-Flex XCCommercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects. | Device | 1C70 to Pro-Flex XC, Pro-Flex XC to 1C70 |
Primary outcome
Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot
Time frame: 2 months after fitting with the last study feet
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for everyday foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot
Time frame: 2 months after fitting with the last study feet
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for comparator foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Change in patient-perceived mobility (PLUS-M) compared to baseline
Time frame: Baseline measurement vs 2 months after fitting with 1C70
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Change in patient-perceived mobility (PLUS-M) compared to the comparator foot
Time frame: 2 months after fitting with each of the study feet
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Highest pain reported: 1C70 vs everyday foot
Time frame: Baseline measurement vs 2 months after fitting with 1C70
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the everyday foot.
Highest pain reported: 1C70 vs comparator foot
Time frame: 2 months after fitting with each of the study feet
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the coparator foot.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 29414988Morgan SJ, McDonald CL, Halsne EG, Cheever SM, Salem R, Kramer PA, Hafner BJ. Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial. PLoS One. 2018 Feb 7;13(2):e0189652. doi: 10.1371/journal.pone.0189652. eCollection 2018.
- Derived from this study: PubMed 39630588Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1C70 and Pro-Flex XC in people with Amputation, run by Otto Bock Healthcare Products GmbH at 6 sites in Germany.
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 11 inclusion and 9 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot (time frame: 2 months after fitting with the last study feet). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628064, which also lists 2 linked publications.
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 10 Jun 2025.