Clinical trials: Amputation of Lower Limb
Critical Limb Ischemia
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
In this clinical research study the investigators will test the efficacy of an innovative, non-invasive methodology to reduce mortality and lower limb loss among high-risk medically-underserved patients with cardiovascular…
- Trial name
- ArtAssist (NCT02054416)
- Testing
- ArtAssist© Device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Temple University
Peripheral Vascular Disease, Diabetic Foot
Autologous Bone Marrow Stem Cell Transplantation for Critical, Limb-threatening Ischemia
Critical limb ischemia is a condition where the blood circulation in the limbs, in most cases the legs, is decreased so that pain and non healing wounds ensue. Mostly, this is a sequel of arteriosclerosis and/or diabetes.
- Conditions
- Peripheral Vascular Disease, Diabetic Foot, Peripheral Arterial Occlusive Disease, Leg Ulcer
- Trial name
- BONMOT (NCT00434616)
- Testing
- Autologous bone marrow cell concentrate transplantation, saline injection
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Franziskus-Krankenhaus
Phantom Limb Pain
Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared…
- Trial name
- NCT02076490
- Testing
- Physical/Occupational therapy
- Volunteers
- 105 people
- Sponsor
- Zuyd University of Applied Sciences
Amputation, Amputation; Traumatic, Leg, Lower
A Comparative Assessment of Transfemoral Prosthetic Sockets
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
- Trial name
- NCT04038580
- Testing
- Laminated Socket, Quatro, Infinite Socket
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
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
Arteritic Leg Ulcer
Anatomical Study of the Arteries of the Skin on Amputation Legs
PRIMARY OBJECTIVE Qualitatively describe the distribution of cutaneous arteries in patients with long-term occlusive arterial disease.
- Trial name
- APIA (NCT03618615)
- Testing
- artericitc surgery
- Volunteers
- 100 people
- Sponsor
- Central Hospital, Nancy, France
Stump Pain
Study of the Efficacy, Safety and Tolerability of Topical 2PX (Strontium Chloride Hexahydrate) in Patients With Chronic, Moderate-to-severe Lower Limb Post-amputation Stump Pain
Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain. Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in stump pain.
- Trial name
- NCT00804375
- Testing
- 2PX
- Where
- 19 sites in Denmark, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- Smerud Medical Research International AS
Phantom Limb Pain, Amputation
Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation
The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower…
- Conditions
- Phantom Limb Pain, Amputation, Anesthesia, Local
- Trial name
- NCT06693427
- Testing
- Peripheral Nerve Block
- Where
- Greece
- Volunteers
- 72 people
- Sponsor
- DIMITRIOS KATSAROS
Diabetes Mellitus, Amputation Stumps
Phototherapy in DM Amputation Ulcers.
Diabetes mellitus is a major public health problem and it is estimated that 300 million individuals will be affected by the year 2030.
- Conditions
- Diabetes Mellitus, Amputation Stumps, Diabetic Foot
- Trial name
- NCT02883751
- Testing
- LED, Control group
- Where
- Brazil
- Sponsor
- University of Nove de Julho
Anesthesia, Amputation; Traumatic, Leg, Lower
Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS)
Major lower limb amputation is recognised as a significant cause of morbidity and mortality. In the United Kingdom, 30-day in-hospital mortality is up to 8.7%.
- Trial name
- ATLLAS (NCT07244627)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University Hospitals of North Midlands NHS Trust
Lower Limb Amputation
Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation
Background: Identifying which variables influence the personalized rehabilitation of patients with lower limb amputation and understanding their interrelationships optimizes resource allocation.
- Trial name
- Amputation (NCT06903637)
- Testing
- Hierarchical Cluster Analysis
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Cigdem Cinar
Amputation, Lower Limb Amputation Knee
Promoting Physical Activity Following Dysvascular Amputation
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death.
- Trial name
- NCT06667739
- Testing
- IMPACT-L3
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- West Park Healthcare Centre
Amputation
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Previous studies suggest that Veterans with below the knee amputation using passive-elastic or powered prostheses have impaired physical function, which could increase the risk of osteoarthritis, leg/back pain, and…
- Trial name
- NCT03974945
- Testing
- Passive-elastic prosthetic foot, Powered ankle-foot prosthesis
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation
Socket Geometry and Clinical Outcomes of Manual vs Digital Sockets for Lower-limb Amputees
The most important aspect of a lower-limb prosthesis is the socket as the interface between the human and the mechanical prosthetic system.
- Trial name
- NCT06504303
- Testing
- 3D-printed socket
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- West Park Healthcare Centre
Infections, Infected Wound
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg
- Trial name
- POvIV2 (NCT05699174)
- Testing
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Where
- 13 sites in United States
- Volunteers
- 250 people
- Sponsor
- Major Extremity Trauma Research Consortium
Amputation, Wound; Foot
Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix
Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute.
- Conditions
- Amputation, Wound; Foot, Wound Complication
- Trial name
- NCT06063694
- Testing
- Synthetic electrospun fiber matrix
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Scripps Health
Amputation, Anesthesia, Local
Use of Long-acting Bupivacaine In Lower Extremity Amputation
The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs.
- Conditions
- Amputation, Anesthesia, Local, Opioid Use
- Trial name
- NCT04360421
- Testing
- Liposomal bupivacaine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Loma Linda University
Lower Extremity Amputation
Weight Loss Intervention for Individuals With Lower Extremity Amputation
The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active.
- Trial name
- MOVE-LEAP (NCT02085785)
- Testing
- Coached group, Self-directed control group, Screened only
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
Amputation
Feasibility of Neural Feedback for Lower Limb Amputees
The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees.
- Trial name
- NCT03409133
- Testing
- Stimulating nerve electrodes and intramuscular recording electrodes
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Louis Stokes VA Medical Center