Clinical trials: Limb Loss
Post-Amputation Pain, Phantom Limb Pain
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
- Trial name
- NCT01996254
- Testing
- SPRINT Peripheral Nerve Stimulation (PNS) System
- Where
- 10 sites in United States
- Volunteers
- 28 people
- Sponsor
- SPR Therapeutics, Inc.
Amputation, Amputation; Traumatic, Hand
Dexterous Partial Hand Prosthesis Outcomes
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User
- Trial name
- NCT05038566
- Testing
- Pointdexter
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Transtibial Amputee
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic…
- Trial name
- NCT03164356
- Testing
- Bioimpedance monitor
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Washington
Spinal Cord Injuries, Amputees
Understanding Quality and Equity in Wheelchairs for Veterans
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL).
- Trial name
- NCT01236170
- Where
- 5 sites in United States
- Volunteers
- 497 people
- Sponsor
- VA Office of Research and Development
Transfemoral Amputation, Unilateral Traumatic Amputation of Leg at or Above Knee
Functional Outcomes in Dysvascular Transfemoral Amputees
In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary…
- Trial name
- CLEG (NCT01537211)
- Testing
- C leg compared to subject's mechanical leg (Otto Bock)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shirley Ryan AbilityLab
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
Amputation, Elderly
Falls in Older Persons With Limb Loss
Lower limb prosthesis users are known to be at a substantially increased fall risk compared to able-bodied individuals. The interaction between increased fall risk, reduced balance confidence and high prevalence of a fear of…
- Trial name
- FOPLL (NCT03670004)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Ischemia
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries…
- Trial name
- NCT02758847
- Testing
- Angiogram, Medtronic DCB (paclitaxel)/stent, Angiogram, Bard DCB (paclitaxel)/stent
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Rabih A. Chaer
Amputation, Transfemoral Amputation
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees.
- Trial name
- NCT06620861
- Testing
- Power Knee Firmware Update, Power Knee Current Marketed Firmware
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
Prostheses and Implants
IceExplore TF Liner Alpha Investigation
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system.
- Trial name
- NCT04787484
- Testing
- IceExplore TF breathable liner and Direct Socket drilled with holes
- Volunteers
- 18 people
- Sponsor
- Össur Iceland ehf
Lower Extremity Amputation
Community Walking Trials: Comparing Prosthetic Feet
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
- Trial name
- NCT03703232
- Testing
- Investigational prosthetic foot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation, Hyperhidrosis
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial using Qbrexza Cloths to treat hyperhidrosis of amputation sites.
- Trial name
- NCT04924036
- Testing
- glycopyrronium cloths
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Utah
Amputation
Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
The overall goal of this project is to develop a virtual neuroprosthesis in which a facsimile of a neural implant is externalized and housed in a well-controlled microfluidic chamber, thereby abating the intrinsic limitations of…
- Trial name
- NCT03581448
- Testing
- Sensory Restoration During Prosthesis Control
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Florida Atlantic University
Bone Loss, Hypotensive
Blood Flow and Bone Density in Healthy Adult Women
This project will test the efficacy of using a non-invasive neuromuscular stimulation on the plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult women.
- Conditions
- Bone Loss, Hypotensive, Lower Limb Fluid Pooling
- Trial name
- NCT00397462
- Testing
- calf muscle pump stimulation
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Binghamton University
Amputation; Traumatic, Hand
To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees
This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment.
- Trial name
- NCT05012683
- Testing
- Point Partial
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Point Designs
Phantom Limb Pain
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb…
- Trial name
- DoD-PLP-Tx (NCT01824082)
- Testing
- Perineural infusion [continuous peripheral nerve block(s)]
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of California, San Diego
Amputation Wound, Traumatic Amputation of Toe
Longitudinal Study of Weight Change Following Lower Limb Amputation
The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation.
- Conditions
- Amputation Wound, Traumatic Amputation of Toe, Dysvascular Amputation of Lower Limb
- Trial name
- NCT00932399
- Where
- United States
- Volunteers
- 4,549 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Prosthesis User
Efficacy of a Vented Liner and Socket System for Individuals With Trans-femoral Amputation
The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator.
- Trial name
- NCT05279885
- Testing
- Vented suspension system, Non-vented suspension system
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jóna Valgerður Kristjánsdóttir
Phantom Limb Pain
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
- Trial name
- NCT02627495
- Testing
- transcranial Direct Current Stimulation (tDCS): (Soterix ©)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Spaulding Rehabilitation Hospital