Clinical trials: Extremity Amputation
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
Peripheral Artery Disease, Vascular Disease
Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
- Conditions
- Peripheral Artery Disease, Vascular Disease, Critical Limb Ischemia
- Trial name
- MarrowCHAMP (NCT02863926)
- Testing
- Injection of cBMA aspirate into the index leg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Michael Murphy
Lower Limb Amputation
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
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.
- Trial name
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
Prostheses, Upper Limb Amputation Below Elbow
Wireless Prosthetic Control Effectiveness Study
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users.
- Trial name
- NCT06821412
- Testing
- ASTERISK System, Wired Configuration
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Liberating Technologies, Inc.
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Trauma Injury
ICG Fluorescence Imaging in Lower Extremity Amputation Patients
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG)…
- Trial name
- NCT04250558
- Testing
- Lower Extremity Amputation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Amputation, Prosthesis User
Shared Decision Making Aid for Prosthetic Design
This study is designed to learn more about decision making for prosthetic design, with the goal of producing a decision making aid for prosthetic design decisions.
- Trial name
- D-MAP (NCT04536025)
- Testing
- Qualitative focus group interviews, Qualitative semi-structured interviews
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- University of Colorado, Denver
Amputation, Diabetes
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain.
- Conditions
- Amputation, Diabetes, Leg Injuries, Traumatic Amputations
- Trial name
- NCT00117793
- Testing
- Total Surface Bearing Suction Socket, Vacuum assisted socket system
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Amputation, Amputation; Postoperative, Sequelae
Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound…
- Conditions
- Amputation, Amputation; Postoperative, Sequelae, Wound Dehiscence, Seroma
- Trial name
- PREVENA-AMP (NCT03773575)
- Testing
- PREVENA™ PEEL & PLACE™ Dressing Kit
- Where
- 3 sites in United States, Italy
- Volunteers
- 272 people
- Sponsor
- Thomas Jefferson University
Amputation of Lower Limb
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated.
- Trial name
- NCT06938087
- Testing
- 3D printed prosthesis foot, Current prosthesis foot
- Where
- Italy
- Volunteers
- 3 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
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
Traumatic Amputation
Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the current standard of care in…
- Trial name
- NCT00942890
- Testing
- NMES (EMPI 300PV stimulator) plus standard of care, TMARP standard of care
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- University of Tennessee
Amputation, Artificial Limb
Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)
The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations.
- Trial name
- NCT04086641
- Testing
- Crossover foot, Energy Storing Foot
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Washington
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.
Traumatic Amputation of Lower Extremity, Phantom Limb Pain
Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day
The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves.
- Trial name
- SCS-90 (NCT04547582)
- Testing
- Spinal cord stimulator
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Lee Fisher, PhD
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.
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Traumatic Amputation of Lower Extremity
Functional Electrical Stimulation Use in Trans-tibial Amputations
The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase…
- Trial name
- NCT02931396
- Testing
- FES
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alicia Koontz
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
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego