Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health (NCT03927404) | Clinical Trial Compass
CompletedNot Applicable
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
United States60 participantsStarted 2020-02-12
Plain-language summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages of 18 and above
* Unilateral transtibial or transfemoral amputee
* Ambulate at a K2 level or higher
* At least 3 months post-amputation per physician discretion
* Residual limb length greater than 6.5 inches in length
* Able to follow directions and give informed consent on their own or through Legally Authorized Representative.
* Must be able to ambulate without assistance. An external assistance device such as cane or walker will be permitted.
* Adequate arterial blood flow as evidenced by a TcOM \>30mmHg measured within the past 12 months.
Exclusion Criteria:
* Conditions that prevent wearing a prosthetic socket,such as existing scab, ulcer, or keloid scar on amputation stump.
* Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ratio of Trans-epidermal Water Loss (TEWL) at 16 Weeks After Use