Clinical trials: Chronic Ulcers of the Lower Limb
Ulcer Venous, Wound Heal
Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs .
- Trial name
- NCT06400875
- Testing
- InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- ConvaTec Inc.
Sickle Cell Anemia, Sickle Cell Disease
Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders
Background: Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease, thalassemia, and other red blood cell disorders.
- Conditions
- Sickle Cell Anemia, Sickle Cell Disease, Chronic Hemolytic Disorders
- Trial name
- NCT01316796
- Testing
- Sodium Nitrite Cream
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Wound Care, Venous Ulcer Care
Effect of Prontosan Wound Irrigation Solution on Venous Ulcers
Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled…
- Conditions
- Wound Care, Venous Ulcer Care, Wound Cleansing, Chronic Wound Care
- Trial name
- NCT01048307
- Testing
- Prontosan wound irrigation solution
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Calvary Hospital, Bronx, NY
Diabetic Foot Ulcer
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
- Trial name
- 1ABC (NCT03865394)
- Testing
- Application of allogeneic ADSC stem cells in fibrin gel, Standard care in diabetic foot ulcer
- Where
- Poland
- Volunteers
- 46 people
- Sponsor
- Medical University of Warsaw
Diabetic Foot Ulcers (DFUs)
Effect of Meso Wound Matrix in the Treatment of DFUs
This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.
- Trial name
- NCT04182451
- Testing
- Meso Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- SerenaGroup, Inc.
Diabetic Ulcers, Venous Leg Ulcer
PMCF Study of Debridement Pad
The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by…
- Conditions
- Diabetic Ulcers, Venous Leg Ulcer, Arterial Leg Ulcer, Pressure Ulcer
- Trial name
- NCT07255937
- Testing
- Debridement Pad
- Where
- Spain
- Volunteers
- 184 people
- Sponsor
- Advanced Medical Solutions Ltd.
Inflammation, Veins
The Role of Pyroptosis in Chronic Venous Disease
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria.
- Conditions
- Inflammation, Veins, Complication, Varicose Veins
- Trial name
- PYROCVD (NCT03744858)
- Testing
- Peripheral blood draw
- Where
- Italy
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Chronic Ulcers
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic…
- Trial name
- NCT07406152
- Testing
- ZKARE®, Standard Wound Care
- Where
- Spain
- Volunteers
- 134 people
- Sponsor
- i+Med S.Coop.
Foot Ulcer, Diabetic
Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2
The goal of this study is to evaluate the safety and efficacy of using mesenchymal stromal cell derivatives (dac-MSCs) in the treatment of chronic diabetic foot ulcers (type 1 and 2) in adults.
- Trial name
- MSCDTDFU (NCT02943486)
- Testing
- dac-MSCs, MSCs, Fitostimoline
- Volunteers
- 51 people
- Sponsor
- Universidad Autónoma de Bucaramanga
Critical Lower Limb Ischemia, Critical Limb Ischemia
Evaluation of Carbothera in the Treatment of Foot Ulcers
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease.
- Conditions
- Critical Lower Limb Ischemia, Critical Limb Ischemia, Foot Ulcer, Skin Ulceration
- Trial name
- NCT02239419
- Testing
- CO2-Enriched Tap Water (Carbothera), Non-CO2-Enriched Tap Water
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Manitoba
Diabetic Foot Ulcer
A Study Measuring the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation as an Adjunctive Treatment in Treating Diabetic Foot Ulcers
The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against usual care.
- Trial name
- NCT03458286
- Testing
- BRH-A2 wound healing device
- Volunteers
- 50 people
- Sponsor
- Royal College of Surgeons, Ireland
Diabetic Foot Ulcer
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects.
- Trial name
- STRIDE 5 (NCT01840085)
- Testing
- 0.03% DSC127 topical gel
- Where
- 21 sites in United States
- Volunteers
- 261 people
- Sponsor
- Integra LifeSciences Corporation
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
Wounds
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer…
- Trial name
- NCT04745806
- Testing
- ActiGraft
- Where
- Israel
- Volunteers
- 6 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer
Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers
This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM.
- Trial name
- NCT07161830
- Testing
- Omeza® Complete Matrix, Standard of Care
- Where
- 10 sites in United States
- Volunteers
- 180 people
- Sponsor
- Omeza, LLC
Chronic Ulcer of Lower Extremity
Plasma On Chronic Wounds for Epidermal Regeneration
Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects.
- Trial name
- POWER (NCT05855499)
- Testing
- CPtcube, CPTpatch
- Where
- 8 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Coldplasmatech
Diabetic Foot, Chronic Foot Ulcer
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.
- Conditions
- Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
- Trial name
- DFUs (NCT05506215)
- Testing
- SynPath Acellular Dermal Matrix plus Off-loading Device, Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcers
Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers
Diabetic foot ulcers are a challenge to health care professionals because there are only few effective topical therapeutic interventions.
- Trial name
- NCT00770939
- Testing
- Vivostat PRF
- Where
- 5 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Vivostat