Clinical trials: Chronic Ulcer of Lower Extremity
Critical Limb Ischemia, Ischemia
VEGF Gene Transfer for Critical Limb Ischemia
The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia…
- Conditions
- Critical Limb Ischemia, Ischemia, Leg Ulcer
- Trial name
- NCT00304837
- Testing
- pVGI.1 (VEGF-2)
- Where
- 3 sites in United States
- Sponsor
- Losordo, Douglas, M.D.
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)
Chronic Diabetic Foot Ulcer
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks.
- Trial name
- NCT00709514
- Testing
- DCB-WH1 ointment
- Where
- Taiwan
- Volunteers
- 41 people
- Sponsor
- Oneness Biotech Co., Ltd.
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
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
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
Chronic Venous Leg Ulcers
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when…
- Trial name
- NCT00797706
- Testing
- CHRONSEAL
- Where
- 16 sites in Norway, Sweden
- Volunteers
- 75 people
- Sponsor
- Kringle Pharma Europe AB
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.
Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users.
- Trial name
- ChloraSolv02 (NCT04838600)
- Testing
- ChloraSolv
- Where
- 7 sites in Sweden
- Volunteers
- 34 people
- Sponsor
- RLS Global
Venous Ulcer
Venous Ulcer Treatment With Foam Versus Conservative Treatment
The venous ulcer due to venous insufficiency causes an important morbility to those people suffering from this condition. Most of therapies available under the obligatory health plan (POS, acronym in spanish) to date cover the…
- Trial name
- VUTEF (NCT01594658)
- Testing
- Foam sclerotherapy, conservative
- Where
- Colombia
- Volunteers
- 46 people
- Sponsor
- Hospital Occidente de Kennedy
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
Pressure Ulcers, Venous Ulcers
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot
- Trial name
- NCT01348581
- Testing
- Marigen Wound Dressing
- Where
- Iceland
- Volunteers
- 37 people
- Sponsor
- Kerecis Ltd.
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