Clinical trials: Amputation
Prosthesis User, Amputation
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and…
- Trial name
- NCT04388488
- Testing
- CONNECT TF adaptable socket system, Any conventional handmade socket
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Össur Iceland ehf
Diabetic Foot
Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot
The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot.
- Trial name
- NCT00224796
- Testing
- V.A.C. ® System
- Volunteers
- 146 people
- Sponsor
- KCI USA, Inc
Amputation; Traumatic, Hand, Amputation, Congenital
To Validate Point Mini User Needs
The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will…
- Trial name
- NCT06504667
- Testing
- Point Mini
- Where
- 2 sites in United States
- Sponsor
- Point Designs
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Diabetic Foot Syndrome
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00537498
- Testing
- Urokinase
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- medac GmbH
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.
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
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
Amputation; Traumatic, Hand
Validation of User Needs of the Point Digit With Partial Hand Amputees
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform…
- Trial name
- NCT04763278
- Testing
- Point Digit
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Point Designs
Transtibial Amputation, Artificial Limbs
Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait.
- Trial name
- NCT04157608
- Testing
- Habitual Prosthesis, Energy-Harvesting Mesofluidic Impulse Prosthesis
- Where
- United States
- Sponsor
- Orthocare Innovations, LLC
Fall Prevention, Balance, Falls
Evaluating Methods to Replicate Stumbles and Slips During Walking
This protocol outlines a study designed to investigate three different methodologies for inducing gait perturbations. Subjects will be divided into two groups: prosthetic users and able-bodied individuals.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07175714
- Testing
- Methodologies to induce gait perturbations
- Where
- 2 sites in Iceland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Össur Iceland ehf
Transfemoral Amputation
Osseointegrated Prostheses for the Rehabilitation of Amputees
Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4.
- Trial name
- OPRA (NCT01725711)
- Testing
- OPRA Implant System
- Where
- Sweden
- Volunteers
- 51 people
- Sponsor
- Integrum
Amputation, Upper Limb
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.
- Trial name
- NCT06539936
- Testing
- Glide, Direct Control
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Infinite Biomedical Technologies
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Patients With Diabetic Foot Syndrome
The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00823225
- Testing
- standard therapy, Urokinase
- Where
- 6 sites in Germany
- Volunteers
- 5 people
- Sponsor
- medac GmbH
Diabetes, Ulceration
Shear and Pressure Reducing Insoles for the Diabetic Foot
We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear.
- Conditions
- Diabetes, Ulceration, Amputation, Foot Deformity
- Trial name
- GlideSoft (NCT00499356)
- Testing
- pressure reducing insole, GlideSoft®
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- Diabetica Solutions Inc.
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
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss.
- Trial name
- NCT06830876
- Testing
- Chattanooga Continuum Device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sara Peterson-Snyder
Foot Ulcer, Diabetic
NEOX® CORD 1K vs Standard of Care in Non-healing Diabetic Foot Ulcers
In this randomized, multi-center, cross-over study, the efficacy and safety of NEOX® CORD 1K will be evaluated in patients suffering from non-healing diabetic foot ulcers.
- Trial name
- CONDUCT I (NCT02166294)
- Testing
- NEOX® CORD 1K, Standard of Care (Pressure Bandage)
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Amniox Medical, Inc.