Clinical trials: Chronic Ulcers of the Lower Limb
Leg Ulcer
EASH Dressing on Chronic Venous Leg Ulcers
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
- Trial name
- NCT01497210
- Testing
- EASH dressing
- Where
- 6 sites in Poland, United Kingdom
- Volunteers
- 40 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcers
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers.
- Trial name
- DFU (NCT01596920)
- Testing
- Tissue, Control
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Osiris Therapeutics
Critical Limb Ischemia, Peripheral Arterial Disease - PAD
Autologous Fat Grafting in the Treatment of Critical Limb Ischaemia
Critical Limb Ischaemia (CLI) is a condition characterized by chronic ischemic at-rest pain, ulcers, or gangrene for more than 2 weeks in one or both legs, attributable to objectively proven arterial occlusive disease.CLI is…
- Conditions
- Critical Limb Ischemia, Peripheral Arterial Disease - PAD, Ischemic Ulcer, Ischemic Feet
- Trial name
- NCT04746599
- Testing
- Autologous Fat Grafting
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Chronic Venous Leg Ulcers
TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
- Trial name
- NCT02936128
- Testing
- TruSkin, Wound Cover
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Osiris Therapeutics
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
Diabetic Foot, Chronic Osteomyelitis
Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections
Diabetic foot ulcers are frequent with average lifetime risk of 15%, and can lead to bone and joint infections. Current protocols for their management include evaluation of ischemia, assessment of underlying bone infection, sharp…
- Conditions
- Diabetic Foot, Chronic Osteomyelitis, Septic Arthritis
- Trial name
- NCT05593874
- Testing
- Histones H3.1 blood levels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Ulcers, Wound - in Medical Care
Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene
This is an interventional double arms pilot study on the effectiveness of hydrogen sulfide (H2S) rich and microbiologically pure spa sulphurous water, in the wound hygiene of hard-to heal wounds, set in an italian spa facility.
- Conditions
- Ulcers, Wound - in Medical Care, Wounds and Injuries, Wound Healing
- Trial name
- NCT06725797
- Testing
- wound hygiene with hypothermal sulfurous water by packs, wound hygiene with hypothermal sulfurous water by limb full immersion
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Roma La Sapienza
Venous Ulcer
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed.
- Trial name
- XCell (NCT00446823)
- Testing
- XCell cellulose wound dressing, Impregnated gauze dressing
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Xylos Corporation
Chronic Venous Disease
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression bandaging accelerates the rate…
- Trial name
- NCT01801891
- Testing
- VASGARD stimulator, Compression bandaging
- Where
- 2 sites in Ireland
- Volunteers
- 25 people
- Sponsor
- Professor Stewart Walsh
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.
Non-healing Wound
Treatment of Wounds Using Oasis® ECM
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
- Trial name
- NCT03632031
- Testing
- Oasis Extracellular Matrix, Standard Care (in control arm)
- Where
- 2 sites in United Kingdom
- Volunteers
- 41 people
- Sponsor
- Cook Biotech Incorporated
Diabetic Foot Ulcer
Safety and Efficacy Study of APIC-PRP in Non-healing Diabetic Foot Ulcers
Patients have a diabetic foot ulcer that is older than 4 weeks and has been treated with physician-selected standard of care treatment such as debridement, hydrogel or saline irrigation, primary dressing, and offloading will be…
- Trial name
- NCT02209662
- Testing
- APIC-PRP
- Volunteers
- 274 people
- Sponsor
- Cytonics Corporation
Diabetic Foot Ulcer
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)
The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs).
- Trial name
- NTCDU (NCT06020664)
- Testing
- NOX-1416+SOC
- Where
- 6 sites in Israel
- Volunteers
- 30 people
- Sponsor
- NOxy Health Products, LLC
Venous Ulcer
Preliminary Testing of New Treatment for Chronic Leg Wounds
The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer.
- Trial name
- NCT01858272
- Testing
- H5.020CMV.PDGF-b and limb compression bandage
- Volunteers
- 15 people
- Sponsor
- University of Pennsylvania
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Transcutaneous Application of Gaseous CO2
The research is designed to evaluate influence of transcutaneous application of CO2 (carbon dioxide) on chronic wound healing. Transcutaneous application of CO2 is known to have immediate effect on vasodilatation and elevates…
- Trial name
- NCT04561609
- Testing
- Transcutaneous CO2 application
- Where
- 3 sites in Croatia, Slovenia
- Volunteers
- 120 people
- Sponsor
- University Medical Centre Ljubljana
Diabetic Foot, Diabetic Foot Ulcer
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- Trial name
- NCT06003530
- Testing
- hOMSC200
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Cytora Ltd.
Chronic Venous Hypertension With Ulcer and Inflammation, Venous Ulcer Pain
Electromagnetic Field Therapy to Improve Healing of Chronically Venous Ulcer
Chronically venous ulcer in lower extremities is a permanent and disabling disease. Venous insufficience is the main cause of chronic ulcer. There is a high prevalence and frequency of the disease, primarily among elderly people.
- Trial name
- NCT01561170
- Testing
- Active Pulsed Electro-Magnetic Field (PEMF)
- Where
- Denmark
- Volunteers
- 36 people
- Sponsor
- Northern Orthopaedic Division, Denmark
Non-Healing Ulcer of Skin, Non-healing Wound
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and…
- Conditions
- Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound
- Trial name
- NCT05739149
- Testing
- Microvessel Ultrasound Examination, Skin Biopsy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Venous Leg Ulcer
Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT06930768
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
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.