Clinical trials: Amputation, Lower Limb
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
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
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
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.
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 (Injury), Congenital Amputation of Lower Limb
Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee…
- Conditions
- Lower Limb Amputation Above Knee (Injury), Congenital Amputation of Lower Limb, Lower Limb Amputation Knee
- Trial name
- ASCENT K2 (NCT04784429)
- Testing
- Kenevo or C-Leg 4, Non microprocessor controlled knee (NMPK)
- Where
- 90 sites in United States
- Volunteers
- 107 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation Stumps, Pain
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
- Trial name
- NCT00592098
- Testing
- Strontium chloride hexahydrate
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- SantoSolve AS
Peripheral Vascular Disease
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Ecraprost in lipid emulsion is being developed for the treatment of Critical leg ischemia (CLI), which is the most severe form of peripheral arterial disease (PAD).
- Trial name
- NCT00059644
- Testing
- Ecraprost in lipid emulsion
- Where
- 27 sites in United States, United Kingdom
- Volunteers
- 560 people
- Sponsor
- Tanabe Pharma Corporation
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