Clinical trials: Amputation, Wound
Hemorrhage, Vascular Injury
A Transparent Elasticized Adhesive Occlusive Compression Bandage for Use as an Arterial Tourniquet
This cross-over study of twenty five (anticipated) healthy human subjects will utilize two active control devices, and two different widths of the investigational device.
- Trial name
- NCT02592655
- Testing
- Pneumatic Tourniquet, One Windlass Tourniquet, Two Windlass Tourniquets
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Marcus Migura
Phantom Limb Pain, Amputation, Traumatic
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four…
- Trial name
- NCT02487966
- Testing
- transcranial Direct Current Stimulation (tDCS): active (Soterix ©), Mirror Therapy: active
- Where
- 2 sites in United States, Brazil
- Volunteers
- 132 people
- Sponsor
- Spaulding Rehabilitation Hospital
Unilateral Traumatic Amputation, Amputation, Traumatic
Determining the Potential Benefit of Powered Prostheses
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
- Trial name
- NCT02828982
- Testing
- Powered ankle prosthesis, Dynamic Response Foot
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Deanna H Gates
Trauma
Investigating Outcomes of Lower Limb Trauma
This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb…
- Trial name
- NCT01691950
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Imperial College London
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
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-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
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
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 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, 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
Chronic Pain, Brain Injuries, Traumatic
Telehealth Pain Self-Management for Employed Adults
The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed.
- Conditions
- Chronic Pain, Brain Injuries, Traumatic, Multiple Sclerosis, Spinal Cord Injuries
- Trial name
- E-TIPS (NCT04248725)
- Testing
- E-TIPS
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- University of Washington
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
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
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine
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
Amputation, Traumatic, Traumatic Amputation of Lower Extremity
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription.
- Conditions
- Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
- Trial name
- NCT02318979
- Testing
- Otto Bock prosthesis, Ossur prosthesis, Freedom Innovations prosthesis
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- VA Eastern Colorado Health Care System
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.
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
Lower Limb Amputation Below Knee (Injury)
Auto Control of Volume Management for Limb Loss
The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using…
- Trial name
- NCT03550118
- Testing
- Adjustable socket
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- University of Washington