Clinical trials: Lower Extremity Amputation
Amputation
Comparative Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot.
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars: 1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a…
- Trial name
- DEFI (NCT06627361)
- Testing
- PRO-FLEX PIVOT Foot evaluation, Class III ESAR Foot evaluation
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Össur Iceland ehf
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, Amputation of Lower Limb
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.
- Conditions
- Amputation, Amputation of Lower Limb, Amputation of Upper Limb, Amputation, Limb Loss
- Trial name
- VANISH (NCT06908538)
- Testing
- cryoablation
- Where
- 6 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- AtriCure, Inc.
Hyperhidrosis, Residual Limbs
Antiperspirant in the Treatment of Residual Limp Hyperhidrosis for Prosthetic Users
The aim of the present pilot study is to evaluate the effect of antiperspirant to treat residual limb hyperhidrosis with the emphasis on the utility of the iodine-starch test to identify the location of the sweating.
- Trial name
- NCT05501444
- Testing
- Topical antiperspirant
- Where
- Norway
- Volunteers
- 7 people
- Sponsor
- Sophies Minde Ortopedi
Fall Prevention, Balance, Falls
Evaluating Stumble Recovery Functions of Prosthetic Knees
The study aims to conduct a formative evaluation, along with verification, validation, and comparative analysis of the stumble recovery function in prosthetic devices by collecting relevant clinical data.
- Conditions
- Fall Prevention, Balance, Falls, Amputation of Lower Limb
- Trial name
- NCT07266454
- Testing
- Prosthetic Knee (e.g Power Knee, Navii, Rheo Knee, ...)
- Where
- 2 sites in Iceland
- Volunteers
- 50 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation Above Knee (Injury)
New Microprocessor-Controlled Prosthetic Knee Evaluation
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK.
- Trial name
- NCT06017024
- Testing
- microprocessor-controlled knee (MPK) assessment
- Where
- 5 sites in France
- Volunteers
- 18 people
- Sponsor
- Proteor Group
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
Amputation
Pro APP Prosthetic Outcome Registry
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
- Trial name
- NCT06210620
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Össur Iceland ehf
Traumatic Amputation of Lower Extremity
Intraosseous Transcutaneous Amputation Prosthesis
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
- Trial name
- (ITAP) (NCT02491424)
- Testing
- Direct skeletal fixation of ITAP to lower limb amputees.
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Stryker Orthopaedics
Diabetic Foot Infection, Diabetic Foot
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot…
- Trial name
- NCT05174806
- Testing
- Topical Pravibismane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Microbion Corporation
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.
Amputation
e-OPRA Implant System for Lower Limb Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004.
- Trial name
- NCT03720171
- Testing
- e-OPRA Implant System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Integrum
Lower Limb Amputation
Evaluation of a Novel Transfemoral Prosthetic Socket System
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system.
- Trial name
- NCT01846845
- Testing
- Conventional Prosthetic Transfemoral Socket System, Novel Prosthetic transfemoral socket system
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Ohio Willow Wood
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.
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
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation
Amputation
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
- Trial name
- NCT01155024
- Testing
- Traditional fabricated prosthetic socket, Direct manufactured (DM) prosthetic socket
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ohio Willow Wood
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
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Study on a Prosthetic Foot With Adjustable Heel Height
Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an…
- Trial name
- ADJUST (NCT07214493)
- Testing
- Taleo Adjust, The usual participant's foot
- Where
- 5 sites in France
- Volunteers
- 30 people
- Sponsor
- Otto Bock France SNC
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