Clinical trials: Extremity Amputation
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Amputation, Prosthesis User
Digital Weight Bearing Shape Capture Socket Technology
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets…
- Conditions
- Amputation, Prosthesis User, Residual Limbs
- Trial name
- DWB (NCT05749952)
- Testing
- Symphonie Aqua Digital System mediated sh
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Indiana University
Amputation, Diabetes Mellitus
Dysvascular Amputation Self-Management of Health
The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.
- Conditions
- Amputation, Diabetes Mellitus, Peripheral Artery Disease
- Trial name
- DASH (NCT04083456)
- Testing
- Walking Biobehavioral Intervention, Attention Control
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Colorado, Denver
Amputation, Surgical, Amputation, Traumatic
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Conditions
- Amputation, Surgical, Amputation, Traumatic, Phantom Limb Pain, Phantom Pain Following Amputation of Lower Limb
- Trial name
- NCT06071715
- Testing
- ACTIVE cryoneurolysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, San Diego
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; Postoperative, Sequelae
Hyperbaric Oxygen and Outcome After Below Knee Amputations
This study is being conducted to assess the utility of hyperbaric oxygen as an adjunctive treatment to reduce postoperative complications.
- Trial name
- NCT04717557
- Testing
- Hyperbaric Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Pain Management
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)
The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom…
- Trial name
- NCT04750538
- Testing
- BreEStim 120, BreEStim 240
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
EmPOWERing Active Seniors With Energy
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
- Trial name
- EASE (NCT02958553)
- Testing
- emPOWER Ankle, Subject's own passive prosthesis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Lower Limb Amputation Above Knee (Injury)
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
- Trial name
- MPK-AOPA (NCT02240186)
- Testing
- Microprocessor Knee (MPK), Non-Microprocessor Knee (NMPK)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
Amputation, Amputation, Traumatic
No Power Bionic Lower Extremity Prosthesis
Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Leg, Lower
- Trial name
- NCT04070105
- Testing
- Compliant Adaptive Energy Storage and Return Foot, AllPro
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Michigan
Critical Limb Ischemia, Peripheral Arterial Disease
Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease
- Trial name
- MOBILE (NCT01049919)
- Testing
- Bone marrow concentration device
- Where
- 25 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Amputation, Upper Limb
RESCU System for Robust Upper Limb Prosthesis Control
This study will compare the use of RESCU [Experimental] Prosthesis with a [Standard] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity.
- Trial name
- RESCU (NCT04043234)
- Testing
- RESCU, Pattern Recognition
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Infinite Biomedical Technologies
Post-Amputation Pain, Phantom Limb Pain
Electrical Nerve Block for Amputation Pain
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
- Conditions
- Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain, Stump Pain
- Trial name
- NCT02221934
- Testing
- Altius
- Where
- 22 sites in United States
- Volunteers
- 607 people
- Sponsor
- Neuros Medical, Inc.
Amputation
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs).
- Trial name
- CP-PRO-01-20 (NCT05392907)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Amputation
Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation
This study involves the functional testing of a new lower extremity prosthesis by healthy, active participants with fully healed transtibial (below knee) amputations.
- Trial name
- NCT03913273
- Testing
- AMI transtibial amputation, Standard transtibial amputation
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Massachusetts Institute of Technology
Lower Limb Amputation, Drop Foot
Evaluating Mobility Interventions in the Real World
This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors.
- Trial name
- NCT04275973
- Testing
- Lower limb prostheses, Orthoses for Drop-foot
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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
Phantom Limb Pain, Postoperative Pain
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous…
- Conditions
- Phantom Limb Pain, Postoperative Pain, Neuroma, Acute Pain
- Trial name
- NCT03484429
- Testing
- Peripheral nerve stimulation, Standard Medical Therapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Amputation, Phantom Limb Pain
Neuromodulation in Lower Limb Amputees
The goal of this study is to investigate the role of transcutaneous spinal cord stimulation on spinal cord excitability in lower limb amputees.
- Conditions
- Amputation, Phantom Limb Pain, Hoffman's Reflex
- Trial name
- NCT04543786
- Testing
- Transcutaneous spinal cord stimulation
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- University of Pittsburgh