Active Studies Seeking Participants

The Amputee Coalition – the leading national organization for people with limb loss – recognizes the value of clinical research in identifying needs, evaluating care, and developing new technologies for people with limb loss.

PDF format requires Acrobat Reader from Adobe. Click here to download the policy that describes the application process through which Amputee Coalition may agree to participate in the recruitment of subjects for research.

If you are a researcher and wish to submit an application for Amputee Coalition’s participation in recruitment as described in the policy, please send an e-mail notification to research@amputee-coalition.org.

Projects Approved for Amputee Coalition Participation

The project(s) on this page are those who have completed all the necessary documentation to assure that the research project’s human subject protocols are approved through a recognized institution’s Institutional Review Board and has provided a statement that there are no commercial conflicts of interest. This listing does not imply endorsement of the Amputee Coalition. Research projects are listed as a service to researchers and the limb loss community. The Amputee Coalition is not responsible for the conduct of the researchers. The sponsoring institution assumes responsibility for researcher conduct.

The purpose of this research study is to evaluate known risk factors of cardiovascular disease (i.e. weight, diet, exercise).

Studies have shown that people who have amputations may have an increased risk of some of these risk factors.

You may benefit from early detection of risk factors of developing cardiovascular disease. However, no benefit can be guaranteed.

Eligibility:

  1. Over the age of 18
  2. > 3 months since most recent surgery
  3. No orthopedic injury treated during past year

OR

Orthopedic injury treated during past year (not major limb loss)

OR

Major limb loss resulting from trauma

Time commitment:

  • 2 visits (baseline & 5 yr follow-up)
  • Each visit ~ 90 minutes

Location of Testing:

  • WRNMMC Nutrition Research Laboratory
  • WRNMMC Amputee Care Service
  • WRNMMC ICHP

If interested, please contact:

Alison Pruziner
(Principal Investigator)
301-295-8527
alison.l.pruziner.civ@mail.mil

Eligibility:

  1. Over the age of 18
  2. Received unilateral, traumatic transtibial amputation

Walking Portion:

  1. Able to complete at least a 10 minute walk without upper extremity support
  2. Completed walking rehabilitation

Running Portion:

  1. Able to complete at least a 10 minute run without upper extremity support

Time Commitment:

Both portions:

4 to 5 months

  • 5 assessments at 2 hours to 2 hours

30 minutes each

  • 24 training visits at 30 minutes each

Walking portion:

2-3 months

  • 3 assessments
  • 12 training visits

Running Portion:

2-3 months

  • 3 assessments
  • 12 training visits

Location of Testing:

  • WRNMMC Amputee Care Service

The purpose of this research study is to see if a retraining program using real-time feedback improves how you walk, run and perform
other functional activities.

You may benefit from this study because the training may improve the way you walk and run. This will hopefully help increase your daily
level of function and help you avoid getting other injuries. However, no benefit can be guaranteed.

Principal Investigator:
Alison Pruziner
301-295-8527
alison.l.pruziner.civ@mail.mil

If interested, please contact:
Amanda Wingate
301-295-8506
awingate@udel.edu

WARNING: Participation requires drug (barbiturates/marijuana; urine) and alcohol (breathalyzer) screening. Positive test results will be disclosed to your command.

Overview: Department of Orthopedics and Rehabilitation at Walter Reed National Military Medical Center (WRNMMC) is currently recruiting up to 60 active duty or veteran Service members with and without lower extremity amputations to participate in a research study at WRNMMC.

Purpose: The purpose of the study is to see how walking changes when completing tasks requiring close attention and response.

Possible Benefits: Information we learn may help us learn about how much attention someone with and without an amputation must pay to his/her walking. Paying more attention to walking may not allow someone to interact and respond with his/her environment, which may impact someone’s safety.

Voluntary Agreement: Your participation is completely voluntary. You will be asked to sign a consent form before beginning the study. Refusal to participate will not result in any penalty or loss of benefits to which you are otherwise entitled.

Time Commitment: You will be part of this study for 1 day. During this time you will be asked to visit the CAREN (Bldg 19, Rm B328) 1 time, and this visit will last approximately 3 hours.

Measurements taken: Biomechanics will be collected while you complete a series of tasks that require you to walk on the treadmill and/or complete tasks that require you to pay close attention.

Eligibility:

  • Military health care beneficiaries
  • Age ≥ 18
  • No injury, transtibial amputation OR transfemoral amputation
  • Can walk on a treadmill for 15 minutes

FOR MORE INFORMATION, CONTACT:

Emma Shaw
301-295-0967
America Building (19), Room B322
emma.shaw3.ctr@mail.mil

Principal Investigator

Alison Pruziner
301-295-8527
America Building (19), Room B315
alison.l.pruziner.civ@mail.mil

The Department of Rehabilitation at Walter Reed National Military Medical Center (WRNMMC) is currently recruiting up to 105 individuals with (and without) lower-extremity trauma or amputations to investigate how spine motion affects loads in the low back, and how these motions/loads are related to the current health of the spine and tissues in the low back.

Eligibility: Age = 18-45 years

Unilateral transtibial or transfemoral amputation, or no injuries
No upper-extremity amputation(s) above the wrist Current (or no) low back pain

Time Commitment: a single 2-hour visit

Location: Biomechanics Laboratory, America Building (19), Room B314

Possible Benefits: Results from this study could improve our understanding of why persons with lower-extremity amputation are susceptible to low back pain.

For more information, contact:
Brad Hendershot, PhD
301.400.3477
America Building (19), Room B-311
bradford.d.hendershot2.ctr@mail.mil

Eligibility
1) Over the age of 18
2) Below-knee amputation on only one leg
3) Over a year since your amputation
4) Able to use your prosthesis, but you have difficulty doing high-level activities, such as running or jumping

Location of Testing
Walter Reed National Military Medical Center

  • Amputee Center
  • Prosthetics and Orthotics Service
  • Military and Advanced Training Center

Time Commitment
One year
First 6 months: 5 clinic visits and 2 prosthetic fittings
Second 6 months: 2 telephone calls to complete questionnaires

Purpose of Study

The purpose of the study is to learn if there are differences between a powered ankle prosthesis and the unpowered prosthesis you currently
wear. We will look at differences in how you walk in both prostheses, if one allows you to use less energy when you walk, and if one allows you to participate in and perform more activities than the other.

There is no guarantee that you will benefit from this study, however other research studies have shown that the use of a powered ankle prosthesis may decrease the stress on your un-amputated leg and may reduce the energy you require to complete daily tasks.

Principle Investigator:
Alison Pruziner
301-295-8527
alison.l.pruziner.civ@mail.mil

If interested, please contact:
Amanda Wingate
301-295-8506
amanda.f.wingate.ctr@mail.mil

Caitlin Mahon
301-400-2097
caitlin.e.mahon.civ@mail.mil

WRNMMC is conducting a s tudy to better understand how
individuals with lower limb amputation learn to walk in new
environments.

Qualifications

  • 18-50 years
  • Able to walk comfortably on a treadmill for 15 minutes
  • Received a unilateral lower limb amputation

OR

  • Uninjured adult

Time Commitment: 2 hours

If interested please contact:
Erik Wolf
301.400.2082
erik.j.wolf6.civ@mail.mil

Version 4: 11/21/2014

What does the study involve?

The purpose of this study is to examine the effect of parental amputation on child psychological function and parenting stress. This study uses an online survey consisting of 89 questions. Anyone who has experienced limb loss within the past 5 years and has a child in the home under the age of 18 may participate in this study.

How long does it take?

The study consists of about 89 questions and should take no longer than 15 minutes to complete.

What do I get for being in the study?

You will be able to participate in psychology research first-hand on a topic that currently has very little research with the hopes that this knowledge will help families with limb loss in the future.

How do I participate?

Enter the link of the study below into your web browser and take the survey online with the password pugetsound.

https://www.surveymonkey.com/s/limblossresearch

Questions about this study may be directed to Dr. Sarah Heavin at sheavin@pugetsound.edu

The purpose of this research project is to obtain first-hand accounts of the various coping styles used by adolescents who have experienced limb loss.
The findings of this study will be presented at Wesleyan College’s Scholarship Day in April.

If you are interested in participating in this study, please contact Rebecca Otwell at rcotwell@wesleyancollege.edu

*Participants must be at least18 years of age

Calling all lower-limb amputees! Your input is needed for development of a new prosthetic foot for hiking and/or biking. Any help is greatly appreciated!

The purpose of this survey is to determine what barriers exist for lower-limb amputees when it comes to hiking over uneven terrain and biking or cycling. By voluntarily participating in this survey, your identity will remain anonymous and confidential as no personal information, other than your age and gender, will be given. If you choose to participate, you are free not to answer any of the given questions. If you have any questions, comments, or concerns about this study, feel free to contact Mark Husack at husack.m@gmail.com or by telephone at (404) 626-0257. Thank you.

Take the survey at surveygizmo.com.

  • We are recruiting individuals with amputation(s) who are interested in learning how to self-manage living with an amputation and trends in current technology.
  • Participation is online.
  • Participation will range from a minimum of 1 week to 1 month (work at your own pace).
  • Participants will receive a $25 gift card after completion of each section of the study for a total of four gift cards = $100.

For Information Contact: Dr. Sandra Winkler, OTR/L
swinkler1@nova.edu
561-328-7659  352-222-9106
Sponsored by AHRQ Grant # 1R24HS022021-01

Researchers at the University of Illinois at Chicago, in collaboration with practitioners at Scheck and Siress Orthotics and Prosthetics, are trying to understand how different socket suspension systems affect how much you use your prosthetic, your balance confidence and your locomotor capabilities.

Your participation would involve filling out short on-line surveys from home. The total time to complete all surveys is 15-20 minutes and you will be compensated for your time.

We are looking for participants that meet the following criteria:

  • Must be at least 18 years of age
  • Must be at least 1 year since amputation
  • Must be using current prosthetic for at least 6 months
  • Must have, or have access to an active email account
  • Must walk without the use of a cane or walker
  • Must answer yes to the following: “I can walk continuously for 6 minutes.”
  • Must not currently use a vacuum assisted socket suspension system

For further information, please contact the primary investigator, Noah Rosenblatt, PhD, at 312-996-2747.

This study is funded by the American Orthotic and Prosthetics Association

Are you at least 18 years old?

Have you had an upper or lower limb amputation for at least 12 weeks and now experience moderate pain?

If you answered YES to these questions, you may be eligible to participate in a phantom limb pain research study.

The purpose of this research study is to determine if putting local anesthetic (numbing medication) through one or two tiny tube(s) placed next to the nerve(s) that go to an amputated limb will decrease phantom limb pain. The procedure, device and infusion are all FDA approved for this purpose. Subjects may experience a decrease in the incidence (if it occurs at all), frequency (how often it occurs), duration (how long each episode lasts), and intensity (how much it hurts) of your phantom and residual limb pain. A reduction in your chronic pain may result in an improvement in how you feel about the rest of your life, including decrease in any depression. In addition, by being part of this study, you may possibly help future patients by helping us to determine if putting local anesthetic through a tiny tube next to the nerves that go to an amputated limb decreases phantom limb pain. Participants will receive $100 following each catheter insertion plus $50/ day during the 6-day infusion(s). Compensation will be mailed via the United States Postal Service following catheter removal.

This study is being conducted at Cleveland Clinic, 9500 Euclid Ave., Cleveland, OH 44195. Other sites also available are University of California in San Diego, California; Walter Reed Army National Military Medical Center in Bethesda, Maryland; Palo Alto Veterans Affairs Medical Center in Palo Alto, California and Naval Medical Center in San Diego, California.

Please call Alparslan Turan, MD (216) 445-9857, Srinivasa Govindarajan, MD (216) 445-5085 or (216) 445-6500 for more information.

Biomet® Biologics is seeking volunteers to participate in a clinical trial to study the safety and effectiveness of a investigational treatment to prevent or delay amputation in patients with a severe form of PAD known as Critical Limb Ischemia (CLI).

Participants will receive either the investigational treatment or a placebo treatment for their condition and attend office visits at weeks 6, 12, 24, 36 and 52, with phone calls occurring at weeks 3, 9, 18, 30 and 44.

The cost of the procedure and follow up clinic visits are covered by the study sponsor. Compensation may be provided for travel-related expenses associated with follow up visits.

For more information about this study, please visit http://www.padstudy.org or, if you prefer to speak to a live operator, please call 1-877-788-3972.

Researchers at Walter Reed National Military Medical Center and Virginia Tech are conducting a telephone survey among lower limb amputees to better understand the causes and circumstances of falls.

We are looking for volunteers who:

  • are between the ages of 18 and 50
  • have an amputation in only one leg

If you have any questions or are willing to participate, please email your first name and phone number to falling.study@gmail.com or call 1-877-495-1556.

Post-amputation pain (PAP) is highly prevalent in all types of amputations, and often a prominent factor in disability, yet we know very little about its pathopsychology. Our preliminary data indicate that PAP subjects usually have autonomic dysregulation in the residual limb and that thermal biofeedback with relaxation training can result in dramatic pain relief in many PAP subjects through the potential mechanism of decreasing sympathetic drive to pathologically sensitized tissue. The preponderance of recent biofeedback literature supports change in self-efficacy and locus of control as the primary therapeutic processes involved in biofeedback associated with pain relief, and it is likely that these cognitive changes account for some of the improvements seen in PAP. However, we hypothesize that enhanced self-efficacy accounts for only a portion of the improvement in pain in post-amputation subjects, and that improvement also correlates strongly and specifically with measurable physiologic changes, especially a diminution in sympathetic efferent tone. In this proposed research, we will assess the relative contribution of cognitive behavioral changes (i.e., self-efficacy) and objective physiologic changes (i.e., vasomotor tone) to decreased pain in PAP during the process of mastering thermal biofeedback, a model for quantitatively and simultaneously assessing a mind-body therapeutic interaction.

We hypothesize that thermal biofeedback and relaxation training will effectively decrease post-amputation pain through the intermediary of “mind” (cognitive, specifically self-efficacy) and “body” (physiologic, specifically decreased sympathetic discharge into an adrenergically sensitized residual limb). Self-efficacy will be shown to have a significant impact on the relationship between biofeedback and pain ratings.

For information regarding participation in this study, please contact Dr. R. Norman Harden at the Rehabilitation Institute of Chicago atnharden@ric.org.

Researchers at Emory University Hospital (Atlanta, Georgia) and the Atlanta VA Medical Center are actively recruiting patients for a study evaluating Hand Transplantation as a potential therapy for the replacement of hand(s) loss. Specifically, we are seeking patients who may be interested in being considered for a hand transplant and participating in a clinical trial designed to determine whether a transplanted hand(s) can help amputees perform their activities of daily living better than an artificial limb prosthesis.

Hand transplantation, like other forms of organ transplantation, requires a major surgical procedure and drug therapy for life after the procedure to maintain the function of the transplanted hand. As such, patients will need to undergo many tests to determine whether they are appropriate for this new therapy prior to being accepted as a trial participant.

If you think that you might be interested in being considered for this study, or if you would like additional information about hand transplantation, please contact Dr. Linda Cendales at 404/727-1731; e-mail: lcendal@emory.edu or Beth Begley, RN at 404/712-1114; email: beth.begley@emoryhealthcare.org.

Additional information about this study can be found at clinicaltrials.gov, trial reference number: NCT0077885.

A multi-center study is underway utilizing an investigational medical device for people with post-amputation pain. If you are experiencing moderate to severe post-amputation pain not controlled by medication, we invite you to learn more.

Qualifications for study participation include:

  • One amputated lower limb
  • Frequent and recurring amputation pain
  • Willingness to undergo surgery
  • 21 years of age or older

The purpose of this clinical study is to evaluate whether electrical nerve block is a safe and effective treatment for patients with post-amputation pain. You will not be charged for any study related appointments or procedures.

For more information please contact: Neuros Medical, Inc., http://www.neurosmedical.com, clinicaltrials@neurosmedical.com