AmputationNCT00985842
Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
A study testing Pe-Lite and sleeve suspension socket, Total Surface bearing a socket with a sleeve suspension but without suction and Total surface bearing suction socket with a pin lock suspension in people with Amputation and Diabetes Complications, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation, Diabetes Complications, Leg Injuries
- What is being tested?
- Pe-Lite and sleeve suspension socket, Total Surface bearing a socket with a sleeve suspension but without suction and Total surface bearing suction socket with a pin lock suspension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2009to 26 Oct 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must meet the following inclusion criteria:
- unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70,
- have been fit with a prosthesis and have used a prosthesis for at least one year,
- wear the prosthesis at least 4 hours per day,
- ambulate without upper extremity aids, and
- have no history of injurious falls within the previous six months.
Who cannot join
- Subjects will be excluded if:
- they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or
- their residual limb is ulcerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Socket System Effect on Tissue Oxygenation During Amputee Gait
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.
Read the detailed description
The amount of oxygen in residual limb tissue is an important health status indicator; resistance to infection, promotion of wound healing, production of collagen, and epithelialization all correlate with higher oxygen levels. Unfortunately, simply donning a lower limb prosthesis may limit circulation and reduce the level of tissue oxygenation. This reduction may be compounded by the biomechanical forces of gait. The compressive loads of the body's weight during stance and the inertial loads of the prosthesis during swing may further occlude circulation, albeit by different mechanisms.
For the dysvascular lower limb amputee, the choice of prosthetic socket and suspension system may impact the overall health of their residual limb and wound healing capacity. An inappropriate choice may lead to skin irritation, tissue breakdown, discomfort, and reduced mobility. For these patients, any component that reduces tissue oxygenation is a significant problem because compromised circulation can forestall wound healing.
The objective of the proposed research is to use photo-oximetry to discover which of five different prosthetic limb systems results in higher residual limb tissue oxygenation during both rest and gait. This experiment will enable evidence-based decision making on this clinically relevant problem. Using a prospective, randomized cross-over experimental design and the investigators' photo-oximetry system, the investigators will measure and compare the tissue oxygenation along the medial and lateral surfaces (3 sites each) of the residual limb during rest and walking.
- Conditions
- Amputation, Diabetes Complications, Leg Injuries, Traumatic Amputation
- Being tested
- Pe-Lite and sleeve suspension socket, Total Surface bearing a socket with a sleeve suspension but without suction, Total surface bearing suction socket with a pin lock suspension, Total surface bearing suction socket with a sleeve suspension, Vacuum-assisted socket system (Harmony System, Otto Bock)
- Keywords
- Artificial limbs, Gait, Oximetry, Prosthesis, Rehabilitation
- Medical subject headings
- Diabetes Complications, Leg Injuries, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pe-Lite and sleeve suspension socketDevice
Prosthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket.
Total Surface bearing a socket with a sleeve suspension but without suctionDevice
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket.
Total surface bearing suction socket with a pin lock suspensionDevice
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee.
Total surface bearing suction socket with a sleeve suspensionDevice
Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension.
Vacuum-assisted socket system (Harmony System, Otto Bock)Device
Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Comparison of five different clinically used suspension and socket systems Receives: Device: Pe-Lite and sleeve suspension socket; Device: Total Surface bearing a socket with a sleeve suspension but without suction; Device: Total surface bearing suction socket with a pin lock suspension; Device: Total surface bearing suction socket with a sleeve suspension; Device: Vacuum-assisted socket system (Harmony System, Otto Bock) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen in tissue
Tissue oxygen saturation (StO2)
Measured: Comparison of five different systems will be performed in one session occurring on one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study start1 Nov 2009
- Primary completion26 Oct 2012
- Study completion26 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Glenn K Klute, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985842
- Sponsor's protocol ID
- A4378-R
- Status last verified
- Jun 2018
- First submitted
- 11 Dec 2007
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket System Effect on Tissue Oxygenation During Amputee Gait
- ClinicalTrials.gov ID
- NCT00985842
- Acronym / sponsor ID
- A4378-R
- Conditions
- Amputation, Diabetes Complications, Leg Injuries, Traumatic Amputation
- Keywords
- Artificial limbs, Gait, Oximetry, Prosthesis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Washington
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 26 Oct 2012 (actual)
- Study completion
- 26 Oct 2012 (actual)
- First posted
- 29 Sep 2009 (estimated)
- 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.
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.
Detailed description
The amount of oxygen in residual limb tissue is an important health status indicator; resistance to infection, promotion of wound healing, production of collagen, and epithelialization all correlate with higher oxygen levels. Unfortunately, simply donning a lower limb prosthesis may limit circulation and reduce the level of tissue oxygenation. This reduction may be compounded by the biomechanical forces of gait. The compressive loads of the body's weight during stance and the inertial loads of the prosthesis during swing may further occlude circulation, albeit by different mechanisms.
For the dysvascular lower limb amputee, the choice of prosthetic socket and suspension system may impact the overall health of their residual limb and wound healing capacity. An inappropriate choice may lead to skin irritation, tissue breakdown, discomfort, and reduced mobility. For these patients, any component that reduces tissue oxygenation is a significant problem because compromised circulation can forestall wound healing.
The objective of the proposed research is to use photo-oximetry to discover which of five different prosthetic limb systems results in higher residual limb tissue oxygenation during both rest and gait. This experiment will enable evidence-based decision making on this clinically relevant problem. Using a prospective, randomized cross-over experimental design and the investigators' photo-oximetry system, the investigators will measure and compare the tissue oxygenation along the medial and lateral surfaces (3 sites each) of the residual limb during rest and walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: Pe-Lite and sleeve suspension socket, Device: Total Surface bearing a socket with a sleeve suspension but without suction, Device: Total surface bearing suction socket with a pin lock suspension, Device: Total surface bearing suction socket with a sleeve suspension, Device: Vacuum-assisted socket system (Harmony System, Otto Bock)Comparison of five different clinically used suspension and socket systems |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70,
- have been fit with a prosthesis and have used a prosthesis for at least one year,
- wear the prosthesis at least 4 hours per day,
- ambulate without upper extremity aids, and
- have no history of injurious falls within the previous six months.
Key exclusion criteria (3 listed)
- they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or
- their residual limb is ulcerated.
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 |
|---|---|---|
| Pe-Lite and sleeve suspension socketProsthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket. | Device | Arm 1 |
| Total Surface bearing a socket with a sleeve suspension but without suctionProsthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket. | Device | Arm 1 |
| Total surface bearing suction socket with a pin lock suspensionProsthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee. | Device | Arm 1 |
| Total surface bearing suction socket with a sleeve suspensionProsthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension. | Device | Arm 1 |
| Vacuum-assisted socket system (Harmony System, Otto Bock)Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb. | Device | Arm 1 |
Primary outcome
Oxygen in tissue
Time frame: Comparison of five different systems will be performed in one session occurring on one day
Tissue oxygen saturation (StO2)
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 29 Jun 2018.
- Click here for more information about this study: Socket System Effect on Tissue Oxygenation During Amputee GaitLink provided by the sponsor.
- 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.
Glenn K Klute, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pe-Lite and sleeve suspension socket, Total Surface bearing a socket with a sleeve suspension but without suction and Total surface bearing suction socket with a pin lock suspension in people with Amputation and Diabetes Complications, run by VA Office of Research and Development 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 6 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 29 Jun 2018. 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?
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?
Oxygen in tissue (time frame: Comparison of five different systems will be performed in one session occurring on one day). 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 29 Jun 2018.