Clinical trials: Below Knee Amputation
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Pain in Trans Femoral and Trans Tibial Amputees
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the…
- Trial name
- AMPUPHANTOM (NCT03789435)
- Testing
- Questionnaire
- Where
- Italy
- Volunteers
- 73 people
- Sponsor
- Istituto Ortopedico Rizzoli
Amputees, Diabetes Complications
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an…
- Trial name
- NCT02445170
- Testing
- Amputation
- Where
- Finland
- Sponsor
- Helsinki University Central Hospital
Amputations, Traumatic
Gait Evaluation of Experienced Below Knee Amputees
Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D…
- Trial name
- NCT00353626
- Where
- Israel
- Volunteers
- 9 people
- Sponsor
- Sheba Medical Center
Wound, Diabetes
Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
1. To explore the pathology of nerve, vascular, and skin in the amputated leg 2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention 3.
- Conditions
- Wound, Diabetes, Amputation
- Trial name
- NCT00840164
- Where
- Taiwan
- Volunteers
- 50 people
- Sponsor
- National Taiwan University Hospital
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
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
Lower Limb Amputation Below Knee (Injury)
The Effects of Small Variations in Shoe Heel Height on Gait in People With a Transtibial Amputation
Prosthetic alignment is important for walking function and walking comfort in people with a transtibial amputation (TTA). Prosthetic alignment is defined as the position of prosthetic parts relative to the body and to each other.
- Trial name
- NCT04641845
- Testing
- Cork inlay wedge
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Sint Maartenskliniek
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.
Transtibial Amputation
Temporary Prosthesis in Traumatic Below-knee Amputation
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting.
- Trial name
- NCT00263497
- Testing
- Temporary tuber-ischii bearing prosthesis
- Where
- Cambodia
- Volunteers
- 20 people
- Sponsor
- University Hospital of North Norway
Amputation Stump
Effect of Early Prosthetic Fitting in Patients With Below-knee Amputation
A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.
- Trial name
- NCT06457659
- Testing
- Early Rehab Group, Delayed Rehab Group
- Where
- Pakistan
- Volunteers
- 50 people
- Sponsor
- Superior University
Surgical Wound, Surgical Site Infection
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination…
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection
- Trial name
- NCT04053946
- Testing
- Next Science Wounds Gels
- Sponsor
- Next Science TM
Peripheral Artery Disease, Critical Limb Ischemia
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion…
- Trial name
- TANGO-3 (NCT04433572)
- Testing
- Temsirolimus
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Mercator MedSystems, Inc.
Diabetes
Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope
The investigators are proposing to conduct this study to compare the ultrasonographic appearance of the sciatic nerve with their corresponding histologic architecture.
- Trial name
- NCT02384447
- Where
- United States
- Sponsor
- University of Toledo Health Science Campus
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
Lower Limb Amputation Above Knee (Injury)
Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
- Trial name
- P20-EMBSUBI (NCT04791163)
- Testing
- Socket evaluation
- Where
- 9 sites in France
- Volunteers
- 25 people
- Sponsor
- Proteor Group
Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically…
- Trial name
- NCT06906055
- Testing
- Multicath, Standard of Care (SOC)
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Summa Therapeutics, LLC
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Lower Limb Amputation Knee, Lower Limb Amputation Below Knee (Injury)
Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Lower Limb Amputation
Clinicians are routinely required to make decisions about fall risk among lower limb prosthesis users. For these decisions, clinicians should use valid, reliable, quantitative, and multidimensional measures of balance test for…
- Trial name
- NCT05095584
- Testing
- 3 meter backward walk test
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tezel Yıldırım Şahan
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
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France.
- Trial name
- ASCOPALL (NCT05803317)
- Testing
- usual care : Evaluation of walking on a baropodometric platform
- Where
- France
- Volunteers
- 130 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes