AmputationNCT04484805
Socket Cooling Effectiveness Take Home Study
A study testing ICE Condition in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Liberating Technologies, Inc. at 2 sites in United States.
Trial summary
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. To address this, Liberating Technologies, Inc. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump
- What is being tested?
- ICE Condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 3 Nov 2020
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have a lower limb absence
- Willing and able to complete outlined tasks
- Must complete and pass our Semmes-Weinstein monofilament test
- Must understand English in order to be properly consented and provide feedback to the study personnel
Who cannot join
- The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
- No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Liberating Technologies, Inc.
Holliston, Massachusetts, 01746
Minneapolis VA
Minneapolis, Minnesota, 55417
About this study
Official title: Continuation of the Development of Moisture Management Liner and Active Cooling System for Improving Residual Limb Skin Care
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
Read the detailed description
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. Studies found increases in socket temperature after the prosthesis was donned (0.8 degrees C) and after 30 minutes of walking (2.5 degrees C). Temperatures were found to remain elevated long after activity cessation and even a rest period of double the duration of the preceding activity period is insufficient to return the limb to its initial temperature. A study suggested that a modest temperature increase of only 2 degrees C may be responsible for reports of thermal discomfort by amputees. Therefore, a small amount of activity can cause the socket temperature to elevate and remain at an uncomfortable level for an extended period of time, which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb interface decreases prosthesis use among amputees who want to remain active in their lives.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
This study will focus on investigating the efficacy of this novel socket cooling technology.
The rationale for this study is to determine how well the new technology can cool the residual limb not only in a controlled laboratory environment, but also in a home environment where the device would ultimately be utilized.
The primary objective of this study is to measure the effects of cooling the residual limb on quality of life (QoL) and functional outcomes. Cooling the residual limb inside the prosthetic socket would result in less sweating and greater comfort while wearing the prosthesis, and ultimately greater function and better quality of life as measured by standard functional and QoL outcome measures.
A two group, prospective, double-blinded, block randomized, crossover study design will be implemented. Research participants will be consented and have baseline activity and socket temperature data collected from their usual prosthesis during normal use (4 weeks). The ICE system will be integrated into a custom, experimental socket for each subject. Two versions of the cooling module will be created: (1) a fully-functional, active ICE cooling module (the so called "ON", or experimental, condition), and (2) a placebo ICE module with the TEC unit replaced with an insulating material layer between the fan and the heat spreader such that even when the system is turned on, minimal heat transfer occurs (the control, or "OFF" condition). An ICE module with a heat spreader will be embedded into the socket and the fan will continue to run whether or not active cooling is engaged for both test conditions; however, no heat will be able to be transferred through the insulating layer in the OFF condition. The TEC inside the ICE unit will not be visible once assembled and the modules will be assembled independently; therefore, both the subject and the tester will be blinded to the condition being tested for both the in-lab and at-home testing. A serial number will be used to identify the assembled units and the master key stored separately.
The participants will be divided into two groups and the order of the experimental conditions will be randomized. Each condition will be tested for 4 weeks. In-lab testing and functional measures will be assessed between testing periods as additional assessments of efficacy of the device. Testing will consist of 4 test site visits, as well as 1-2 visits to create and align the experimental socket. The entire study will continue for 3 months.
Lower limb prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will represent a convenience sample and will reflect the local population of both above-knee (AK) and below-knee (BK) amputees of various K-levels using a variety of suspension types who could benefit from temperature control within the socket.
A maximum of 20 subjects will be recruited for this study. This is increased from the target 16 subjects to account for any drop-outs, etc.
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower, Prosthesis User, Lower Limb Amputation Below Knee (Injury)
- Being tested
- ICE Condition, Sham Condition
- Keywords
- cooling, amputee, lower limb absence, prosthesis, prosthetic leg, transtibial, below knee amputation, lower limb difference, lower limb loss, socket, prosthetist, sweat, active, walking, prosthetic liner, prosthetic sock, perspiration, moisture, heat, thermal
- Medical subject headings
- Wounds and Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE ConditionDevice
Also called Cooling Unit, ICE Unit
Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
Sham ConditionDevice
Also called Sham Unit
Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
| Study group | Role | What they receive |
|---|---|---|
| ICE Unit | Experimental | The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. Receives: Device: ICE Condition |
| Sham Unit | Sham comparator | The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. Receives: Device: Sham Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Limb Temperature
This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill.
The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Aug 2019
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vivonics, Inc.
- Responsible party
- Principal investigator, Todd Farrell, Liberating Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484805
- Sponsor's protocol ID
- 120180039
- Other IDs
- W81XW-17-C-005
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2020
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of the Development of Moisture Management Liner and Active Cooling System for Improving Residual Limb Skin Care
- ClinicalTrials.gov ID
- NCT04484805
- Acronym / sponsor ID
- 120180039
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower, Prosthesis User, Lower Limb Amputation Below Knee (Injury)
- Keywords
- cooling, amputee, lower limb absence, prosthesis, prosthetic leg, transtibial, below knee amputation, lower limb difference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Vivonics, Inc.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
Detailed description
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. Studies found increases in socket temperature after the prosthesis was donned (0.8 degrees C) and after 30 minutes of walking (2.5 degrees C). Temperatures were found to remain elevated long after activity cessation and even a rest period of double the duration of the preceding activity period is insufficient to return the limb to its initial temperature. A study suggested that a modest temperature increase of only 2 degrees C may be responsible for reports of thermal discomfort by amputees. Therefore, a small amount of activity can cause the socket temperature to elevate and remain at an uncomfortable level for an extended period of time, which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb interface decreases prosthesis use among amputees who want to remain active in their lives.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
This study will focus on investigating the efficacy of this novel socket cooling technology.
The rationale for this study is to determine how well the new technology can cool the residual limb not only in a controlled laboratory environment, but also in a home environment where the device would ultimately be utilized.
The primary objective of this study is to measure the effects of cooling the residual limb on quality of life (QoL) and functional outcomes. Cooling the residual limb inside the prosthetic socket would result in less sweating and greater comfort while wearing the prosthesis, and ultimately greater function and better quality of life as measured by standard functional and QoL outcome measures.
A two group, prospective, double-blinded, block randomized, crossover study design will be implemented. Research participants will be consented and have baseline activity and socket temperature data collected from their usual prosthesis during normal use (4 weeks). The ICE system will be integrated into a custom, experimental socket for each subject. Two versions of the cooling module will be created: (1) a fully-functional, active ICE cooling module (the so called "ON", or experimental, condition), and (2) a placebo ICE module with the TEC unit replaced with an insulating material layer between the fan and the heat spreader such that even when the system is turned on, minimal heat transfer occurs (the control, or "OFF" condition). An ICE module with a heat spreader will be embedded into the socket and the fan will continue to run whether or not active cooling is engaged for both test conditions; however, no heat will be able to be transferred through the insulating layer in the OFF condition. The TEC inside the ICE unit will not be visible once assembled and the modules will be assembled independently; therefore, both the subject and the tester will be blinded to the condition being tested for both the in-lab and at-home testing. A serial number will be used to identify the assembled units and the master key stored separately.
The participants will be divided into two groups and the order of the experimental conditions will be randomized. Each condition will be tested for 4 weeks. In-lab testing and functional measures will be assessed between testing periods as additional assessments of efficacy of the device. Testing will consist of 4 test site visits, as well as 1-2 visits to create and align the experimental socket. The entire study will continue for 3 months.
Lower limb prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will represent a convenience sample and will reflect the local population of both above-knee (AK) and below-knee (BK) amputees of various K-levels using a variety of suspension types who could benefit from temperature control within the socket.
A maximum of 20 subjects will be recruited for this study. This is increased from the target 16 subjects to account for any drop-outs, etc.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICE Unit | Experimental | Device: ICE ConditionThe subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. |
| Sham Unit | Sham comparator | Device: Sham ConditionThe subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have a lower limb absence
- Willing and able to complete outlined tasks
- Must complete and pass our Semmes-Weinstein monofilament test
- Must understand English in order to be properly consented and provide feedback to the study personnel
Key exclusion criteria (2 listed)
- The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
- No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb
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 |
|---|---|---|
| ICE ConditionAlso: Cooling Unit, ICE UnitExperimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket. | Device | ICE Unit |
| Sham ConditionAlso: Sham UnitExperimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket. | Device | Sham Unit |
Primary outcome
Residual Limb Temperature
Time frame: 4 hours
This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE Condition in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Liberating Technologies, Inc. at 2 sites 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 4 inclusion and 2 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 22 Oct 2024). 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?
Residual Limb Temperature (time frame: 4 hours). 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 22 Oct 2024.