Clinical trials: Chronic Limb-threatening Ischemia
Peripheral Arterial Disease
Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular
The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter…
- Trial name
- BIBLIOS (NCT03845543)
- Testing
- Luminor-14 Paclitaxel eluting balloon
- Where
- 9 sites in Belgium, Italy and 1 more
- Volunteers
- 150 people
- Sponsor
- ID3 Medical
Critical Limb Ischemia
YQ23 Study in Patients With Critical Limb Ischaemia
This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia.
- Trial name
- YAN (NCT04792008)
- Testing
- YQ23
- Where
- 2 sites in Hong Kong
- Volunteers
- 5 people
- Sponsor
- New Beta Innovation Limited
Critical Limb Ischemia
Alprostadil as an Adjuvant Therapy With Indirect Angiosomal Revascularization in Critical Limb Ischemia.
The aim of this study is to assess the efficacy of Alprostadil (Prostaglandin E2) as adjuvant therapy after failure of direct but indirect angiosomal revascularization in patients with critical limb ischemia.
- Trial name
- NCT04312555
- Testing
- Alprostadil
- Volunteers
- 30 people
- Sponsor
- Assiut University
Critical Limb Ischemia
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
PAD is caused by an increased flow resistance in atherosclerotic ischemic limbs. The investigators hypothesize that reducing blood viscosity (through controlled phlebotomy), thereby increasing the deformability of red blood…
- Trial name
- CLI-PH (NCT01758874)
- Testing
- phlebotomy
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Seoul Veterans Hospital
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
Chronic Limb-Threatening Ischemia
Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients
Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs.
- Trial name
- PROMOTEGLASS (NCT06186544)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Cardiff and Vale University Health Board
Limb Ischemia
Nanofat Grafting as a Method of Treating Critical Limb Ischemia
This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior…
- Trial name
- NCT06357936
- Testing
- nano-fat grafting in chronic limb ischaemia
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Center of New Medical Technologies
Critical Limb Ischemia, Peripheral Arterial Disease
Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease
- Trial name
- RESTORE (NCT03041259)
- Testing
- Rejuveinix Low Dose, Rejuveinix High Dose
- Volunteers
- 320 people
- Sponsor
- Reven Pharmaceuticals, Inc.
Diabetes Mellitus, Critical Limb Ischemia
Laboratory, Cellular and Molecular Determinants of Clinical Success in Diabetic Patients With Critical Limb Ischemia
The ECAD-CLI is an investigator-driven, prospective, single-center study. The aim of the study is to prospectively collect clinical, laboratory, angiographic, cellular and molecular variables related to prognosis and outcome in…
- Conditions
- Diabetes Mellitus, Critical Limb Ischemia, Critical Lower Limb Ischemia, Diabetic Foot
- Trial name
- ECAD-CLI (NCT03636867)
- Testing
- data and specimen collection
- Where
- Italy
- Volunteers
- 236 people
- Sponsor
- Maria Cecilia Hospital
Cardiovascular Disease, Peripheral Artery Disease
Platelet Activity in Vascular Surgery and Cardiovascular Events
Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis.
- Conditions
- Cardiovascular Disease, Peripheral Artery Disease, Critical Limb Ischemia
- Trial name
- PACE (NCT02106429)
- Where
- United States
- Volunteers
- 246 people
- Sponsor
- NYU Langone Health
PAOD - Peripheral Arterial Occlusive Disease, PAD
Recombinant SeV-hFGF2/dF Injection for PAOD
Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs.
- Conditions
- PAOD - Peripheral Arterial Occlusive Disease, PAD, Critical Limb Ischemia
- Trial name
- NCT03668353
- Testing
- Recombinant SeV-hFGF2/dF Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Peripheral Arterial Disease
Use of Indocyanine Green Angiography in Critical Limb Ischemia
Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with…
- Trial name
- FLUORESCENCE (NCT02820467)
- Testing
- fluorescence angiography
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Grenoble
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)
In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure…
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Critical Limb Ischemia
- Trial name
- EVTI-PAD (NCT05570019)
- Testing
- Revascularization
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University Innsbruck
Critical Limb Ischemia
Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery.
- Trial name
- EXERCISE (NCT04043078)
- Testing
- Exercise
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Vascular Disease, Critical Lower Limb Ischemia
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
- Trial name
- NCT00633659
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Sangart
Peripheral Artery Disease, Quality of Life
VADOplex Critical Limb Ischemia Study
In patients with critical limb ischemia (CLI) and foot ulcers wound healing is an important goal which can normally only be achieved after sufficient treatment of the underlying ischemia (revascularization either by an operation…
- Conditions
- Peripheral Artery Disease, Quality of Life, Wound Healing
- Trial name
- NCT02034539
- Testing
- VADOplex system
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Asklepios Kliniken Hamburg GmbH
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Peripheral Arterial Disease, Claudication
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)
The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.
- Conditions
- Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT00883246
- Testing
- SilverHawk & TurboHawk Peripheral Plaque Excision System
- Volunteers
- 800 people
- Sponsor
- Medtronic Endovascular
Diabetes, Critical Limb Ischemia
Diabetic Foot and Vascular Progenitor Cells
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl. Follow up visit will be after 12 months from the enrollement.
- Trial name
- NCT01269580
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- IRCCS Multimedica
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs
Viennese Registry on Patients With Chronic Critical Limb Ischemia
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real…
- Trial name
- NCT01233141
- Where
- Austria
- Volunteers
- 400 people
- Sponsor
- Medical University of Vienna