Clinical trials: Amputation
Symptomatic Neuroma, Amputation
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention…
- Conditions
- Symptomatic Neuroma, Amputation, Chronic Nerve Pain
- Trial name
- REPOSE-XL℠ (NCT04865679)
- Testing
- Axoguard Nerve Cap®
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Axogen Corporation
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Diabetes Mellitus, Type 2, Cardiovascular Diseases
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation.
- Trial name
- NCT03492580
- Testing
- Canagliflozin, Empagliflozin, Dapagliflozin
- Where
- United States
- Volunteers
- 714,582 people
- Sponsor
- Janssen Research & Development, LLC
Diabetic Amputation Foot Wound
A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation.
- Trial name
- VAC 2006-19 (NCT00837096)
- Testing
- V.A.C. Therapy, Moist wound therapy (MWT)
- Volunteers
- 19 people
- Sponsor
- KCI USA, Inc
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Research on Wireless Brain Implant System for General Control of External Devices
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive…
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- RISE (NCT06829212)
- Testing
- WRS
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Shanghai StairMed Technology Co., Ltd.
Amputation; Traumatic, Hand
Validation of Point Partial User Needs With Partial Finger Amputees
The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to…
- Trial name
- NCT05012657
- Testing
- Point Partial
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Point Designs
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, 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.
Diabetes Mellitus, Type 2
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation…
- Trial name
- NCT04937816
- Testing
- Empagliflozin
- Where
- Germany
- Volunteers
- 16,746 people
- Sponsor
- Boehringer Ingelheim
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT06194838
- Testing
- Ossur Power Knee, Reboocon Intuy Knee
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Liberating Technologies, Inc.
Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee…
- Conditions
- Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee
- Trial name
- ASCENT K2 (NCT04784429)
- Testing
- Kenevo or C-Leg 4, Non microprocessor controlled knee (NMPK)
- Where
- 90 sites in United States
- Volunteers
- 107 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Lower Limb Amputation
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System
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
- NCT01839123
- Testing
- Prosthetic Suction or Pin Socket, Prosthetic LimbLogic Vacuum Socket
- Where
- 2 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
Prosthesis User, Prosthesis
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits…
- Conditions
- Prosthesis User, Prosthesis, Prosthetic, Upper Limb Amputation
- Trial name
- NCT07850544
- Testing
- Condition A: Electrode Configuration, Condition B: Electrode Configuration, Condition C: Electrode Configuration
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, Inc.
Amputation Wound, Peripheral Arterial Disease
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.
- Trial name
- WISCR (NCT03611361)
- Testing
- SpectralMD DeepView Wound Imaging System 2.0
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- SpectralMD
Amputation, Prosthesis User
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Trial name
- NCT05190354
- Testing
- Xtremity Polymer Prosthetic Socket
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Medical Creations, Inc.
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Amputation, Prosthesis User
Metabolic Cost of Walking With Passive vs. Powered Microprocessor Controlled Knees
This study is conducted to evaluate the efficacy of the Power Knee Mainstream Dynamic compared to passive microprocessor-controlled knees (MPKs) regarding metabolic cost for high active transfemoral amputees.The test is of a…
- Trial name
- NCT05048355
- Testing
- Power Knee Mainstream Dynamic, Passive microprocessor controlled knee
- Where
- 2 sites in Germany, Iceland
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Prosthesis User, Lower Limb Amputation Below Knee (Injury)
Caesar Foot Take-Home Validation Testing
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment.
- Trial name
- NCT07075198
- Testing
- Caesar Foot
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Liberating Technologies, Inc.
Amputation; Traumatic, Hand, Amputation, Congenital
To Assess the Utility of the Point Mini in a Clinical Take-home Study
The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device.
- Trial name
- NCT06501092
- Testing
- Point Mini
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Point Designs