Clinical trials: Chronic Ulcer of Lower Extremity
Diabetic Foot, Foot Ulcer
Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds
The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of…
- Conditions
- Diabetic Foot, Foot Ulcer, Leg Ulcer, Bacteremia
- Trial name
- ORISA (NCT01551667)
- Testing
- Antibody assays for S. aureus, Basic blood work
- Where
- 6 sites in France
- Volunteers
- 69 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Venous Leg Ulcer
Randomized Controlled Trial for Treatment of Pain and Assessment of Wound Healing in Chronic Venous Leg Ulcers Using Near Infrared Laser Therapy
The laser emits an infrared light that heats the skin and underlying tissues with the purpose of temporary relief of minor muscle and joint pain, as well as stiffness associated with arthritis.
- Trial name
- NCT03716167
- Testing
- Summus Laser
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
Wound Infection Bacterial, Ulcer Foot
Wound Infection Detection Evaluation, WIDE
Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and can lead to complications with high morbidity, particularly if the wound if infected.
- Conditions
- Wound Infection Bacterial, Ulcer Foot, Diabetic Foot, Diagnostic Self Evaluation
- Trial name
- WIDE (NCT03883230)
- Testing
- GLYWD
- Where
- United Kingdom
- Volunteers
- 256 people
- Sponsor
- Cumbria Partnership NHS Foundation Trust
Diabetic Foot, Diabetes Complications
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers
Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application…
- Trial name
- NCT00292357
- Testing
- Application of autologous bone marrow
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Heidelberg University
Diabetic Foot, Diabetic Neuropathies
Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy
This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by…
- Conditions
- Diabetic Foot, Diabetic Neuropathies, Diabetic Foot Ulcer
- Trial name
- PDSC (NCT06373809)
- Testing
- Transplantation of Placenta Derived Stem Cells
- Where
- 2 sites in Nicaragua
- Volunteers
- 20 people
- Sponsor
- Michael H Carstens
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcer (DFU)
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in…
- Trial name
- NCT07116174
- Testing
- Xcell Amnio Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 135 people
- Sponsor
- New Horizon Medical Solutions
Diabetic Foot Ulcer
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
The goal of this study is to evaluate the safety and efficacy of an advanced therapy medicinal product containing live allogeneic adipose-derived mesenchymal stem cells (ADSC/ASC) for the treatment of diabetic foot ulcers in a…
- Trial name
- FOOTCELL (NCT06843122)
- Testing
- Allogeneic ADSC/ASC (alloADSC-DFU-RL)
- Where
- Poland
- Volunteers
- 105 people
- Sponsor
- Medical University of Warsaw
Diabetic Foot Ulcer
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus…
- Trial name
- PREPARE (NCT06618612)
- Testing
- Standard of Care, PuraPly AM, PuraPly XT
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
Venous Leg Ulcer, Autologous Adipose Stromal Vascular Fraction
Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers
To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.
- Conditions
- Venous Leg Ulcer, Autologous Adipose Stromal Vascular Fraction, Adipose-Derived Mesenchymal Stem Cells, Mesenchymal Stem Cells
- Trial name
- NCT05165459
- Testing
- Venous leg ulcer treatment with adipous SVF
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Szeged University
Diabetic Foot Ulcer
The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85…
- Trial name
- NCT06584617
- Testing
- Berovenal®, NU-GEL Hydrogel with Alginate
- Where
- 9 sites in Germany, Poland
- Volunteers
- 66 people
- Sponsor
- VULM s.r.o.
Chronic Venous Hypertension With Ulcer and Inflammation, Chronic Ulcer of Leg or Foot
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers.
- Trial name
- NCT03526913
- Testing
- PRP, STSG
- Volunteers
- 20 people
- Sponsor
- Noha Mohsen Omar
Foot Ulcer, Diabetic, Diabetic Angiopathies
Efficacy of a Low-Molecular-Weight Heparin (Bemiparin) in the Treatment of Chronic Foot Ulcers in Diabetic Patients
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
- Trial name
- NCT00399425
- Testing
- bemiparin (low molecular weight heparin)
- Volunteers
- 84 people
- Sponsor
- Spanish National Health System
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Critical Limb Ischemia (CLI), Diabetic Foot
Intraarterial Infusion of Autologous Bone Marrow in Diabetic Patients With Chronic Ischemia of Lower Limbs (CLI) no Revascularization
The aim of the study is to evaluate the safety and feasibility of autologous bone marrow mononuclear cells autologous administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the…
- Trial name
- NCT00987363
- Testing
- Intraarterial infusion of autologous bone marrow cells
- Where
- 5 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Venous Leg Ulcer (VLU)
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Lower Extremity Chronic Ulcers in Diabetics, Diabetic Foot Ulcer (DFU)
Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
- Trial name
- NCT07219004
- Testing
- amniotic membrane
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tides Medical