AmputationNCT00117793
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
A study testing Total Surface Bearing Suction Socket and Vacuum assisted socket system in people with Amputation and Diabetes, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Diabetes, Leg Injuries
- What is being tested?
- Total Surface Bearing Suction Socket and Vacuum assisted socket system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 and less than 70 years of age,
- Have a below knee amputation involving only one side,
- If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months,
- If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year,
- Wear the prosthesis for at least 6 hours a day,
- Able to walk without a cane, crutches, or a walker,
- Are moderately active enough to walk at a steady pace for at least 30 minutes.
Who cannot join
- Have pain in legs or any condition that interferes with walking.
- Have an ulcer on the residual limb,
- If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor,
- Have fallen within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
About this study
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system.
The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.
Read the detailed description
A proper fitting prosthetic socket provides the amputee with a comfortable system allowing them to pursue many of their desired vocational and recreational goals. Unfortunately, many amputees live with an ill-fitting socket and can experience limb pistoning within the socket, which in turn may result in skin irritation, tissue breakdown, discomfort, and a reduction in activity. One of the key factors affecting fit is intraday residual limb volume changes. For an amputee with dysvascular conditions, the implications of a poor fitting socket are exacerbated by poor circulation, reduced healing potential and the compressive forces exerted by their prosthesis.
Vacuum suspension systems may have the potential to alleviate these conditions for healthy and dysvascular amputees. The purported benefits of vacuum suspension systems include, but are not limited to: improved suspension (reduction in the amount of pistoning), maintenance of limb volume throughout the day, and increased tissue oxygenation to the residual limb.
Our first objective is to characterize performance, as related to socket fit, of a vacuum suspension system using objective and subjective measures. We will do this by conducting a within-subject experiment to measure pistoning in three dimensions while walking, overall and regional changes in limb volume before and after a thirty-minute treadmill walk, mobility (step counts) and the perception of socket fit (questionnaire) as a function of prosthetic prescription (vacuum suspension system vs. total surface bearing suction socket).
Our second objective is to determine the effect of pressures within a prosthetic socket on residual limb transcutaneous oxygen tension (tcpO2) levels. We will conduct laboratory-based, in situ testing to determine how the transcutaneous oxygen tension levels, at six sites on the residual limb, respond to pressures simulating those within a vacuum suspension system and a total surface bearing suction socket.
The proposed research will allow us to understand how suspension systems influence prosthetic socket fit and residual limb tissue health and to formulate a knowledge base on two suspension systems providing prosthetists and clinicians the objective data to make better prescription decisions. In addition, the methods utilized in this study (e.g., a residual limb limb volume scanner and assessing dynamic pistoning) can be used to study current and novel suspension systems, liners, and prosthetic socket designs to provide a standard for comparison.
- Conditions
- Amputation, Diabetes, Leg Injuries, Traumatic Amputations
- Being tested
- Total Surface Bearing Suction Socket, Vacuum assisted socket system
- Keywords
- Amputee, Artificial limbs, Gait, Walking
- Medical subject headings
- Diabetes Mellitus, Leg Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Surface Bearing Suction SocketDevice
Current clinical practice
Vacuum assisted socket systemDevice
Novel socket system
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Current clinical practice Receives: Device: Total Surface Bearing Suction Socket |
| Arm 2 | Experimental | Novel socket system Receives: Device: Vacuum assisted socket system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Volume
Measured: Measurements were taken after wearing the study prostheses for three weeks
Activity Level
Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).
Measured: Two weeks
Limb Pistoning
Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.
Measured: Measurements were taken after wearing the study prosthesis for three weeks
Secondary outcomes (3)
Residual Limb Health (PEQ Scale)
Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful).
Measured: Measurements were taken after wearing the study prosthesis for four weeks
Ambulation (PEQ Scale)
Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on).
Measured: Measurements were taken after wearing the study prosthesis for four weeks
Frustration (PEQ Scale)
Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating).
Measured: Measurements were taken after wearing the study prosthesis for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2008
- Study completionSep 2008
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.
- Publications (1)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glenn K. Klute, PhD, Principal investigator, VA Puget Sound Health Care System, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117793
- Sponsor's protocol ID
- A3666
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2005
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Klute GK, Berge JS, Biggs W, Pongnumkul S, Popovic Z, Curless B. Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. Arch Phys Med Rehabil. 2011 Oct;92(10):1570-5. doi: 10.1016/j.apmr.2011.05.019.
PubMed 21963124
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
- ClinicalTrials.gov ID
- NCT00117793
- Acronym / sponsor ID
- A3666
- Conditions
- Amputation, Diabetes, Leg Injuries, Traumatic Amputations
- Keywords
- Amputee, Artificial limbs, Gait, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Jul 2005 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system.
The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.
Detailed description
A proper fitting prosthetic socket provides the amputee with a comfortable system allowing them to pursue many of their desired vocational and recreational goals. Unfortunately, many amputees live with an ill-fitting socket and can experience limb pistoning within the socket, which in turn may result in skin irritation, tissue breakdown, discomfort, and a reduction in activity. One of the key factors affecting fit is intraday residual limb volume changes. For an amputee with dysvascular conditions, the implications of a poor fitting socket are exacerbated by poor circulation, reduced healing potential and the compressive forces exerted by their prosthesis.
Vacuum suspension systems may have the potential to alleviate these conditions for healthy and dysvascular amputees. The purported benefits of vacuum suspension systems include, but are not limited to: improved suspension (reduction in the amount of pistoning), maintenance of limb volume throughout the day, and increased tissue oxygenation to the residual limb.
Our first objective is to characterize performance, as related to socket fit, of a vacuum suspension system using objective and subjective measures. We will do this by conducting a within-subject experiment to measure pistoning in three dimensions while walking, overall and regional changes in limb volume before and after a thirty-minute treadmill walk, mobility (step counts) and the perception of socket fit (questionnaire) as a function of prosthetic prescription (vacuum suspension system vs. total surface bearing suction socket).
Our second objective is to determine the effect of pressures within a prosthetic socket on residual limb transcutaneous oxygen tension (tcpO2) levels. We will conduct laboratory-based, in situ testing to determine how the transcutaneous oxygen tension levels, at six sites on the residual limb, respond to pressures simulating those within a vacuum suspension system and a total surface bearing suction socket.
The proposed research will allow us to understand how suspension systems influence prosthetic socket fit and residual limb tissue health and to formulate a knowledge base on two suspension systems providing prosthetists and clinicians the objective data to make better prescription decisions. In addition, the methods utilized in this study (e.g., a residual limb limb volume scanner and assessing dynamic pistoning) can be used to study current and novel suspension systems, liners, and prosthetic socket designs to provide a standard for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Total Surface Bearing Suction SocketCurrent clinical practice |
| Arm 2 | Experimental | Device: Vacuum assisted socket systemNovel socket system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 and less than 70 years of age,
- Have a below knee amputation involving only one side,
- If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months,
- If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year,
- Wear the prosthesis for at least 6 hours a day,
Key exclusion criteria (4 listed)
- Have pain in legs or any condition that interferes with walking.
- Have an ulcer on the residual limb,
- If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor,
- Have fallen within the last 3 months.
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 |
|---|---|---|
| Total Surface Bearing Suction SocketCurrent clinical practice | Device | Arm 1 |
| Vacuum assisted socket systemNovel socket system | Device | Arm 2 |
Primary outcome
Limb Volume
Time frame: Measurements were taken after wearing the study prostheses for three weeks
Activity Level
Time frame: Two weeks
Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).
Limb Pistoning
Time frame: Measurements were taken after wearing the study prosthesis for three weeks
Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.
3 secondary outcomes
Residual Limb Health (PEQ Scale)
Time frame: Measurements were taken after wearing the study prosthesis for four weeks
Ambulation (PEQ Scale)
Time frame: Measurements were taken after wearing the study prosthesis for four weeks
Frustration (PEQ Scale)
Time frame: Measurements were taken after wearing the study prosthesis for four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21963124Klute GK, Berge JS, Biggs W, Pongnumkul S, Popovic Z, Curless B. Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. Arch Phys Med Rehabil. 2011 Oct;92(10):1570-5. doi: 10.1016/j.apmr.2011.05.019.
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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.
Glenn K. Klute, PhD principal investigator
VA Puget Sound Health Care System, Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Surface Bearing Suction Socket and Vacuum assisted socket system in people with Amputation and Diabetes, run by US Department of Veterans Affairs at 1 site 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 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 15 Aug 2014). 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?
Limb Volume (time frame: Measurements were taken after wearing the study prostheses for three weeks). The study lists 3 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 NCT00117793, which also lists 1 linked publication.
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 15 Aug 2014.