Prostheses and ImplantsNCT04787484
IceExplore TF Liner Alpha Investigation
A study testing IceExplore TF breathable liner and Direct Socket drilled with holes in people with Prostheses and Implants, run by Össur Iceland ehf.
Trial summary
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system. IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostheses and Implants
- What is being tested?
- IceExplore TF breathable liner and Direct Socket drilled with holes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2020to 30 Nov 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 < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Unilateral/bilateral trans-femoral amputees
- Activity level: high K2-K4
- Liner: Össur Seal-In TF silicone liner
- Socket: All subjects shall be using Direct Socket, and have been for minimum 4 weeks
Show all 11Show fewer
- Willing and able to participate in the study and follow the protocol
- Confident prosthetic users for more than 3 months
- Older than 18 years
- Residual limb profile: Standard or conical. At least 30% of subjects must be either conical or standard.
- Subgroup: Minimum 10 subjects shall fit inclusion for subgroup of amputees with history of skin issues.
Who cannot join
- 50Kg> body weight > 136Kg
- Users with cognitive impairment
- Participating in another research study
About this study
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system.
IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.
Read the detailed description
This design iteration investigation will be a single group prospective repeated measures (AB) design. Up to 25 amputees will be recruited in total from both investigational sites and followed-up for 12 weeks, all subjects will be invited to extend period up to additional 3 months.
Recruitment Potential subjects will be identified from the customer base of the Principal Investigator (PI). PI 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 PI will contact them via telephone. During the phone call the PI will verify if they are interested in participating in a study. If interest is expressed at this point, the CPO will go through the Enrollment Log, subjects will answer some screening questions (Screening Questionnaire) and provide their profile information (Profile).
If the eligibility criteria are met an appointment will be made for Site Visit 1 and signing of the Informed Consent Form. 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 PI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate and provide results from Screening Questionnaire and Profile.
Test procedure There are five scheduled study events. Three investigational site visits. Site Visit 1 (baseline), Site Visit 2 (4 weeks follow-up) and Site Visit 3 (12 weeks follow-up). Two follow-up phone calls will be made, one after 2 weeks and one after 8 weeks, Phone Call Checklists will be administered through phone, including video calls, if applicable.
Up to 25 study subjects will be recruited in total.
Site Visit 1 (baseline):
At the first site visit, a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
Prior to fitting, the subject will provide feedback on their current liner (Study Subject Questionnaire Baseline and Study Subject Usability Baseline).
Next step will be fitting of the investigational device. All subjects will be fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Additionally, subjects' sockets will be drilled with holes, as previously described.
It is expected that some subjects might need a new socket, this can be because of limb volume changes and/or other reasons. The Principal Investigator oversees this decision, and if deemed necessary, a new Direct Socket TF will be made, on site, during the time of the first site visit.
At the end of Site Visit 1, all subjects will be provided with a new appointment to come back to the clinic after 4 weeks. All subjects will leave the clinic wearing the investigational device. Subjects will get a copy of the Potential Product Failures Sheet to be able to monitor any product failures and asked to call Principal Investigator, whenever needed.
Each CPO subject will answer one CPO Usability Questionnaire at the end of the Site Visit 1 regarding their experience of fitting/training of the investigational device.
Site Visit 2 (4-week follow-up):
After 4 weeks of using the investigational device, each subject will come in for the second site visit. The main purpose with this visit is for the CPO to meet each subject, evaluate the durability of the investigational device and discuss if there are any problems that have occurred. Subjects will answer Study Subject Questionnaire 4 weeks follow-up and Study Subject Usability 4 weeks follow-up, same set of questions as for baseline.
Follow-up Phone Calls:
Follow-up Phone calls will be made at 2 weeks and 8 weeks and subjects will answer set of check-up questions (Phone Call Checklist).
Site Visit 3 (12-week follow-up):
The last test procedure is the third site visit, subjects will provide feedback on the investigational device by filling in set of questions (Study Subject Questionnaire 12 weeks follow-up). At this point, the condition (durability) of the investigational device will be evaluated by Principal Investigator, CPO and Co-Investigators. If the condition evaluation is deemed acceptable and subject is interested, subjects will be invited to wear the investigational device for up to additional 3 months. If not interested or condition of device is not acceptable, subjects will return their investigational device and will be fitted to their previous device. All will be provided with a new Direct Socket, if needed.
Subjects might be asked to come in for additional visits throughout the study timeline (unscheduled visits) in case of product failure or any other problems that might occur during the investigation that requires further evaluation.
During all site visits, photos will be taken of both baseline liner, test liner and residual limb.
- residual limb
- baseline on limb (only Site Visit 1)
- test liner on limb Also photos of specific current skin issues in any areas on limb All information from site visits and phone calls, including the questionnaires will be sent to study monitor immediately after each procedure, study monitor will report the results to product designers, results will be evaluated, and actions taken if required.
See Table 1 below.
- Conditions
- Prostheses and Implants
- Being tested
- IceExplore TF breathable liner and Direct Socket drilled with holes
- Keywords
- prosthesis, amputee, trans-femoral, liner, seal, silicone, sweat, moisture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceExplore TF breathable liner and Direct Socket drilled with holesDevice
The IceExplore TF liners are similar in intended use, methods of operation and materials to other seal-in TF silicone liners manufactured by Össur. The main difference is that the internal structure of the predicate liner is formed entirely of airtight silicone whereas the proximal 70% (approx.) of the IceExplore TF liner consists of a breathable structure, allowing water vapor to move both transversely away from the skin and longitudinally towards the proximal edge of the prosthetic socket.
The investigational device is a part of a prosthesis system targeted for users with lower extremity amputation (trans-femoral amputees), physically fit for using a prosthesis to replace the function of an amputated lower limb.
| Study group | Role | What they receive |
|---|---|---|
| IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability | Experimental | The primary objective of this investigation will be to evaluate perceived secure suspension and perceived moisture on skin.
The secondary objective will be to evaluate subjects skin health and perceived comfort.
Thirdly, to evaluate perceived stability and suspension during increased perspiration and hygiene.
Additionally, usability parameters will be explored, both for amputees and CPOs. Amputees usability such as inverting liner, donning/doffing liner and socket, ease of cleaning the liner, number of instances that the user dons/doffs socket per one day and general user satisfaction of the amputee will be explored.
Subjects mobility will be evaluated between comparator (baseline) and investigational device with the use of PLUS-M (Prosthetic Limb Users Survey of Mobility). Receives: Device: IceExplore TF breathable liner and Direct Socket drilled with holes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Perceived Socket Suspension Score at 12 Weeks Equal or Above 72%
The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable.
In this study, the CLASS Suspension subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the security of suspension during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized suspension score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived suspension.
Measured: 12 weeks
Difference in Average Perceived Moisture on Skin With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
PEQ item Q is one question from Prosthetic Evaluation Questionnaire (PEQ) - "Over the past four weeks rate how much you sweat inside your prosthesis (in the sock, liner, socket)". A self-reported measure on a scale from 1-10 were 1 is extreme amount of sweat and 10 is no sweat at all.
Measured: 12 weeks
Secondary outcomes (5)
Difference in Average Perceived Skin Health With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
PEQ Residual Limb Health (PEQ-RLH) is a set of 6 questions. The scale has been validated for internal consistency and temporal stability. The questions are self-reported on a scale 1-10 about sweat, smell, swollen limb, rashes, ingrown hairs and blisters or sores. Participants rated each item on a 10-point Likert scale, where higher scores indicated better residual limb health and fewer skin-related problems. The overall PEQ-RLH score was calculated as the mean of the six item scores
Measured: 12 weeks
Difference in Average Perceived Comfort With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable.
In this study, the CLASS Comfort subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the socket comfort during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized comfort score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived comfort.
Measured: 12 weeks
Difference in Average Perceived Stability During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Perceived stability during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, more stability. "When experiencing increased perspiration, during activities of daily living, I feel stable in the socket".
Measured: 12 weeks
Difference in Average Perceived Suspension During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Perceived suspension during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, better suspension. "When experiencing increased perspiration, during activities of daily living, suspension between my residual limb and liner feels".
Measured: 12 weeks
Difference in Average Perceived Hygiene With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
Perceived hygiene evaluated with Prosthetic Evaluation Questionnaire, item R (Over the past 4 weeks rate how smelly your prosthesis was at its worst. A self-reported measure on a scale from 1-10 were 1 is extremely smelly and 10 is no at all smelly.
Measured: 12 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 start5 Oct 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 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 Prostheses and ImplantsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT04787484
- Sponsor's protocol ID
- CIP2019112674
- 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
- IceExplore TF Liner Alpha Investigation
- ClinicalTrials.gov ID
- NCT04787484
- Acronym / sponsor ID
- CIP2019112674
- Conditions
- Prostheses and Implants
- Keywords
- prosthesis, amputee, trans-femoral, liner, seal, silicone, sweat, moisture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 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.
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system.
IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.
Detailed description
This design iteration investigation will be a single group prospective repeated measures (AB) design. Up to 25 amputees will be recruited in total from both investigational sites and followed-up for 12 weeks, all subjects will be invited to extend period up to additional 3 months.
Recruitment Potential subjects will be identified from the customer base of the Principal Investigator (PI). PI 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 PI will contact them via telephone. During the phone call the PI will verify if they are interested in participating in a study. If interest is expressed at this point, the CPO will go through the Enrollment Log, subjects will answer some screening questions (Screening Questionnaire) and provide their profile information (Profile).
If the eligibility criteria are met an appointment will be made for Site Visit 1 and signing of the Informed Consent Form. 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 PI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate and provide results from Screening Questionnaire and Profile.
Test procedure There are five scheduled study events. Three investigational site visits. Site Visit 1 (baseline), Site Visit 2 (4 weeks follow-up) and Site Visit 3 (12 weeks follow-up). Two follow-up phone calls will be made, one after 2 weeks and one after 8 weeks, Phone Call Checklists will be administered through phone, including video calls, if applicable.
Up to 25 study subjects will be recruited in total.
Site Visit 1 (baseline):
At the first site visit, a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
Prior to fitting, the subject will provide feedback on their current liner (Study Subject Questionnaire Baseline and Study Subject Usability Baseline).
Next step will be fitting of the investigational device. All subjects will be fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Additionally, subjects' sockets will be drilled with holes, as previously described.
It is expected that some subjects might need a new socket, this can be because of limb volume changes and/or other reasons. The Principal Investigator oversees this decision, and if deemed necessary, a new Direct Socket TF will be made, on site, during the time of the first site visit.
At the end of Site Visit 1, all subjects will be provided with a new appointment to come back to the clinic after 4 weeks. All subjects will leave the clinic wearing the investigational device. Subjects will get a copy of the Potential Product Failures Sheet to be able to monitor any product failures and asked to call Principal Investigator, whenever needed.
Each CPO subject will answer one CPO Usability Questionnaire at the end of the Site Visit 1 regarding their experience of fitting/training of the investigational device.
Site Visit 2 (4-week follow-up):
After 4 weeks of using the investigational device, each subject will come in for the second site visit. The main purpose with this visit is for the CPO to meet each subject, evaluate the durability of the investigational device and discuss if there are any problems that have occurred. Subjects will answer Study Subject Questionnaire 4 weeks follow-up and Study Subject Usability 4 weeks follow-up, same set of questions as for baseline.
Follow-up Phone Calls:
Follow-up Phone calls will be made at 2 weeks and 8 weeks and subjects will answer set of check-up questions (Phone Call Checklist).
Site Visit 3 (12-week follow-up):
The last test procedure is the third site visit, subjects will provide feedback on the investigational device by filling in set of questions (Study Subject Questionnaire 12 weeks follow-up). At this point, the condition (durability) of the investigational device will be evaluated by Principal Investigator, CPO and Co-Investigators. If the condition evaluation is deemed acceptable and subject is interested, subjects will be invited to wear the investigational device for up to additional 3 months. If not interested or condition of device is not acceptable, subjects will return their investigational device and will be fitted to their previous device. All will be provided with a new Direct Socket, if needed.
Subjects might be asked to come in for additional visits throughout the study timeline (unscheduled visits) in case of product failure or any other problems that might occur during the investigation that requires further evaluation.
During all site visits, photos will be taken of both baseline liner, test liner and residual limb.
- residual limb
- baseline on limb (only Site Visit 1)
- test liner on limb Also photos of specific current skin issues in any areas on limb All information from site visits and phone calls, including the questionnaires will be sent to study monitor immediately after each procedure, study monitor will report the results to product designers, results will be evaluated, and actions taken if required.
See Table 1 below.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability | Experimental | Device: IceExplore TF breathable liner and Direct Socket drilled with holesThe primary objective of this investigation will be to evaluate perceived secure suspension and perceived moisture on skin. The secondary objective will be to evaluate subjects skin health and perceived comfort. Thirdly, to evaluate perceived stability and suspension during increased perspiration and hygiene. Additionally, usability parameters will be explored, both for amputees and CPOs. Amputees usability such as inverting liner, donning/doffing liner and socket, ease of cleaning the liner, number of instances that the user dons/doffs socket per one day and general user satisfaction of the amputee will be explored. Subjects mobility will be evaluated between comparator (baseline) and investigational device with the use of PLUS-M (Prosthetic Limb Users Survey of Mobility). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 50Kg< body weight < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Unilateral/bilateral trans-femoral amputees
- Activity level: high K2-K4
- Liner: Össur Seal-In TF silicone liner
Key exclusion criteria (3 listed)
- 50Kg> body weight > 136Kg
- Users with cognitive impairment
- Participating in another research study
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 |
|---|---|---|
| IceExplore TF breathable liner and Direct Socket drilled with holesThe IceExplore TF liners are similar in intended use, methods of operation and materials to other seal-in TF silicone liners manufactured by Össur. The main difference is that the internal structure of the predicate liner is formed entirely of airtight silicone whereas the proximal 70% (approx.) of the IceExplore TF liner consists of a breathable structure, allowing water vapor to move both transversely away from the skin and longitudinally towards the proximal edge of the prosthetic socket. The investigational device is a part of a prosthesis system targeted for users with lower extremity amputation (trans-femoral amputees), physically fit for using a prosthesis to replace the function of an amputated lower limb. | Device | IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability |
Primary outcome
The Average Perceived Socket Suspension Score at 12 Weeks Equal or Above 72%
Time frame: 12 weeks
The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Suspension subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the security of suspension during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized suspension score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived suspension.
Difference in Average Perceived Moisture on Skin With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
PEQ item Q is one question from Prosthetic Evaluation Questionnaire (PEQ) - "Over the past four weeks rate how much you sweat inside your prosthesis (in the sock, liner, socket)". A self-reported measure on a scale from 1-10 were 1 is extreme amount of sweat and 10 is no sweat at all.
5 secondary outcomes
Difference in Average Perceived Skin Health With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
Difference in Average Perceived Comfort With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
Difference in Average Perceived Stability During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
Difference in Average Perceived Suspension During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
Difference in Average Perceived Hygiene With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
Time frame: 12 weeks
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 IceExplore TF breathable liner and Direct Socket drilled with holes in people with Prostheses and Implants, 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 11 inclusion and 3 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?
The Average Perceived Socket Suspension Score at 12 Weeks Equal or Above 72% (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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.