AmputationPADSNCT01546311
Evaluation of a Pro-Active Dynamic Accommodating Socket
An observational study of Amputation, run by Infoscitex Corporation at 2 sites in United States.
Trial summary
The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputation
- What is being tested?
- Pro Active Dynamic Accommodating Socket
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study.
Who may be able to join
- transfemoral or transtibial amputation
- unilateral or bilateral amputation
- stable residual limb volume
- read, write, and speak English for proper consent and responding to questionnaire
Who cannot join
- evidence or history of residual limb skin conditions such as irritation or sores
- presence of phantom limb pain
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Liberating Technologies, Inc
Holliston, Massachusetts, 01746
Elizabeth Klodd, 508-893-6363 ext. 23, liz.klodd@liberatingtech.com
- Enrolling by invitation
Next Step O&P
Newton, Massachusetts, 02461
About this study
The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.
Read the detailed description
The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls.
- Conditions
- Amputation
- Being tested
- Pro Active Dynamic Accommodating Socket
- Keywords
- prosthetic socket, residual limb volume fluctuation, instantaneous bladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro Active Dynamic Accommodating SocketDevice
Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb
| Study group | Role | What they receive |
|---|---|---|
| lower limb amputees | Not described Receives: Device: Pro Active Dynamic Accommodating Socket |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infoscitex Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liberating Technologies, Inc., Telemedicine & Advanced Technology Research Center
- Responsible party
- Principal investigator, Kristen Leroy, Infoscitex Corporation
- Investigators
- Kristen J LeRoy, Principal investigator, Infoscitex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546311
- Sponsor's protocol ID
- IST1387 PADSII
- Other IDs
- W81XWH-09-C-0028
- Acronym
- PADS
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pro-Active Dynamic Accommodating Socket
- ClinicalTrials.gov ID
- NCT01546311
- Acronym / sponsor ID
- PADS / IST1387 PADSII
- Conditions
- Amputation
- Keywords
- prosthetic socket, residual limb volume fluctuation, instantaneous bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Infoscitex CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Liberating Technologies, Inc., Telemedicine & Advanced Technology Research Center
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Mar 2012 (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.
The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.
Detailed description
The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lower limb amputees | – | Device: Pro Active Dynamic Accommodating Socket |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with transfemoral or transtibial amputation who have been using a prosthesis for at least one month will be recruited for this study.
Key inclusion criteria (4 listed)
- transfemoral or transtibial amputation
- unilateral or bilateral amputation
- stable residual limb volume
- read, write, and speak English for proper consent and responding to questionnaire
Key exclusion criteria (2 listed)
- evidence or history of residual limb skin conditions such as irritation or sores
- presence of phantom limb pain
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 |
|---|---|---|
| Pro Active Dynamic Accommodating SocketSocket with bladders that instantaneously adjusts to volume fluctuations in the residual limb | Device | lower limb amputees |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
Kristen J LeRoy principal investigator
Infoscitex Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Infoscitex Corporation 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: status not confirmed, as of the sponsor's last update on 7 Mar 2012. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Klodd (508-893-6363 ext. 23, liz.klodd@liberatingtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Mar 2012; AzTrials last refreshed its copy on 27 Oct 2026.