Clinical trials: Chronic Leg Ulcer
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
Chronic Venous Disease, Varicose Ulcer
Effects of Local Insulin on Varicose Ulcers for Wound Healing
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm.
- Conditions
- Chronic Venous Disease, Varicose Ulcer, Wound Healing, Insulin
- Trial name
- NCT04310280
- Testing
- Insulin Glargine, Saline
- Where
- Mexico
- Volunteers
- 13 people
- Sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
Foot Ulcer, Diabetic
Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds
On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical study evaluating the efficacy…
- Trial name
- DiaFu (NCT01480362)
- Testing
- Negative Pressure Wound Therapy, Standard Wound Therapy
- Where
- 42 sites in Germany
- Volunteers
- 360 people
- Sponsor
- University of Witten/Herdecke
Venous Leg Ulcer (VLU)
OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.
The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound…
- Trial name
- NCT07754526
- Testing
- Omeza OCM™ Wound Matrix, Routine Care
- Where
- United States
- Volunteers
- 254 people
- Sponsor
- Omeza, LLC
Diabetic Foot, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
Diabetic Foot Ulcer
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial…
- Trial name
- NCT00765063
- Testing
- Fragmin
- Where
- 27 sites in Austria, Belgium and 12 more
- Volunteers
- 62 people
- Sponsor
- Pfizer
Diabetes Mellitus
Hyperbaric Oxygenation in Diabetic Ulcer
Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an increase of total oxygen in the body.
- Trial name
- NCT02042339
- Testing
- Hyperbaric oxygen
- Where
- Austria
- Volunteers
- 80 people
- Sponsor
- Medical University of Graz
Venous Leg Ulcer, Bacterial Infections
Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
- Conditions
- Venous Leg Ulcer, Bacterial Infections, Chronic Ulcer of Skin of Lower Limb Nos
- Trial name
- CUCO-UV (NCT03667937)
- Testing
- CUTIMED, AQUACEL silver
- Where
- Spain
- Volunteers
- 204 people
- Sponsor
- University of Malaga
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds.
- Trial name
- COMBAT-H (NCT07872930)
- Testing
- Irrigation Solution for wounds, Hydrogel for wound care
- Volunteers
- 96 people
- Sponsor
- University of Calgary
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
Venous Leg Ulcer
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)
The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.
- Trial name
- NCT06489028
- Testing
- allo-APZ2-CVU
- Where
- 15 sites in United States, Austria and 10 more
- Volunteers
- 250 people
- Sponsor
- RHEACELL GmbH & Co. KG
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
Diabetic Foot Ulcer
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers
- Trial name
- NCT06455475
- Testing
- Derm-Maxx
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Capsicure, LLC
Neuropathic Foot Ulcer, Foot Ulcer
Vaporous Hyperoxia Therapy (VHT) in the Treatment of Foot Wounds
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT), previously named Misty (WTS-1000) for the treatment of chronic foot ulcers.
- Trial name
- VHT1 (NCT04244201)
- Testing
- Vaporous Hyperoxia Therapy
- Volunteers
- 31 people
- Sponsor
- Vaporox
Diabetic Foot Ulcer, Diabetes
Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic…
- Trial name
- NCT02328508
- Testing
- Hyperbaric oxygen therapy
- Volunteers
- 38 people
- Sponsor
- Chen-Yu Chen
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.
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
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.
- Conditions
- Peripheral Arterial Disease, Critical Limb-Threatening Ischemia, Diabetic Foot
- Trial name
- PiPER (NCT06277362)
- Where
- 9 sites in Italy
- Volunteers
- 50 people
- Sponsor
- EndoCore Lab s.r.l.
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
Chronic Ulcer, Venous Ulcer
Efficacy of PICO Single-use System in Chronic Ulcers
A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.
- Conditions
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
- Trial name
- NCT05877378
- Testing
- Single-use negative pressure therapy (PICO)
- Where
- Spain
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha