Clinical trials: Ischemic Foot Ulcer
Chronic Limb-Threatening Ischemia, Diabetic Foot
Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making
This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to…
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot, Vascular Diseases
- Trial name
- NCT06542523
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Peripheral Arterial Disease, Diabetic Foot
Implementation of ABI and WIfI in Rural Health Clinics
The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for…
- Conditions
- Peripheral Arterial Disease, Diabetic Foot, Diabetes Mellitus
- Trial name
- NCT04337723
- Testing
- ABI/WIFI scoring
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- University of California, Davis
Diabetic Foot Ulcer
Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care
A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus…
- Trial name
- NCT04332003
- Testing
- Remote Ischemic Conditioning (RIC) Treatment
- Sponsor
- SerenaGroup, Inc.
Critical Limb Ischemia, Diabetic Foot
Autologous Peripheral Blood Mononuclear Cells in Diabetic Foot Patients With No-option Critical Limb Ischemia
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
- Trial name
- NCT04255004
- Testing
- Pall Celeris System, point of care device for human cell therapy
- Volunteers
- 76 people
- Sponsor
- Ospedale San Donato
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
Diabetic Foot, Diabetes Mellitus
Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness ("immediate" treatment, within 48h) has advantages…
- Conditions
- Diabetic Foot, Diabetes Mellitus, Peripheral Arterial Disease, Diabetic Neuropathies
- Trial name
- PTA-DFS (NCT06124586)
- Testing
- Percutaneous transluminal angioplasty
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetic Foot Ulcer, Diabetic Angiopathies
Remote Ischemic Conditioning and Diabetic Foot Ulcers
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC.
- Trial name
- NCT04567563
- Testing
- Remote Ischemic conditioning (RIC)
- Volunteers
- 50 people
- Sponsor
- Des Moines University
Diabetic Foot
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia
Diabetic foot patients with chronic limb ischemia and without the option for surgical or interventional revascularization were recruited and randomized to the transplant groups or the control group within this clinical trial.
- Trial name
- NCT01065337
- Testing
- tissue repair cells (TRC), bone marrow stem cells (BMC)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Ruhr University of Bochum
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
Skin Lesion, Traumatic Ulcer
Clinical Investigation EUCLIDES-01 for the Calculation of the Area of Skin Lesions
The aim of this clinical investigation is to collect skin lesion area data for the comparison of the agreement among the results obtained between the following three wound area measurement methods: Ruler using the Kundin method…
- Conditions
- Skin Lesion, Traumatic Ulcer, Hematoma, Pressure Ulcer
- Trial name
- NCT05729334
- Testing
- Clinicgram Euclides
- Where
- Spain
- Volunteers
- 65 people
- Sponsor
- Skilled Skin S.L.
Diabetes, Foot Ulcers
Outcomes of Non-infected Diabetic Foot Ulcers With/Without Antibiotics
The overall objective is to investigate whether antibiotics in the treatment of clinically clean neuropathic and ischaemic ulcers in diabetic foot patients could reduce the incidence of infection and therefore lead to improved…
- Conditions
- Diabetes, Foot Ulcers, Infection
- Trial name
- KADFUT (NCT01418456)
- Testing
- antibiotics
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- King's College Hospital NHS Trust
Peripheral Vascular Disease, Diabetic Foot Ulcer
Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?
The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral…
- Conditions
- Peripheral Vascular Disease, Diabetic Foot Ulcer, Amputation
- Trial name
- DIONYSIUS (NCT05804097)
- Testing
- Hyperbaric oxygen
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ischemic Foot Ulcer
Intensive Insulin Treatment and Ischemic Foot Ulcer
We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional…
- Trial name
- NCT01957930
- Testing
- Intensified insulin treatment, Standard treatment
- Where
- 2 sites in Sweden
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
Diabetic Foot, Gangrene; Limb
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor…
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed
- Trial name
- MetaMet (NCT05804565)
- Testing
- Bone Saw, Bone Cutter
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- University College Hospital Galway
Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer
Seltoplasmid Plus Revascularization for Diabetic Infrapopliteal Chronic Limb-Threatening Ischemia
The goal of this clinical trial is to learn whether Seltoplasmid Injection can improve outcomes after lower-extremity revascularization. Revascularization is a procedure used to restore blood flow to the leg.
- Conditions
- Chronic Limb-Threatening Ischemia, Diabetic Foot Ulcer, Infrapopliteal Arterial Occlusive Disease
- Trial name
- NCT07827521
- Testing
- Lower-Extremity Revascularization, Donaperminogene Seltoplasmid
- Where
- 6 sites in China
- Volunteers
- 180 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Diabetes Mellitus, Type 1, Ischemia
Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs
Diabetic foot ulcers often progresses after many years of diabetes where the patients system is so damaged that normal heeling of ulcers cannot happen.
- Conditions
- Diabetes Mellitus, Type 1, Ischemia, Foot Ulcer
- Trial name
- NCT01614379
- Where
- 2 sites in Denmark
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Critical Limb Ischemia, Claudication, Intermittent
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound…
- Trial name
- PAT (NCT06007469)
- Volunteers
- 50 people
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
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