Clinical trials: Leg Ulcer
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., 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
Diabetes Mellitus, Foot Ulcer
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury…
- Conditions
- Diabetes Mellitus, Foot Ulcer, Neuroischemic Foot Ulcer
- Trial name
- REOXDFU (NCT05413746)
- Testing
- Reoxcare antioxidant dressing
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Histocell, S.L.
Diabetic Foot Ulcers
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic…
- Trial name
- NCT02844660
- Testing
- EpiCord, Standard of Care
- Where
- 13 sites in United States
- Volunteers
- 130 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer
Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer
The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers.
- Trial name
- NCT06231771
- Testing
- Allogeneic mesenchymal stem cells (MSCs), Normal Saline
- Volunteers
- 22 people
- Sponsor
- Supergenics Life Science Sdn. Bhd.
Venous Leg Ulcers, Mixed Leg Ulcers
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs.
- Trial name
- NCT01036438
- Testing
- Mepilex Ag, Mepilex without Ag
- Where
- 44 sites in Czechia, France and 2 more
- Volunteers
- 201 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcers
dHACM Mesh In the Treatment of Diabetic Foot Ulcers
A single-centered, non-randomized study with approximately 20 subjects that will be seen for up to 12 weeks, each receiving the EpiFix mesh plus standard of care. Safety and effectiveness will be monitored throughout the study.
- Trial name
- NCT02589210
- Testing
- EpiFix Mesh
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- MiMedx Group, Inc.
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetic Foot Ulcer, Diabetic Foot
Evaluation of DIAMEL® Combined With Insulin in Diabetic Foot Ulcer
Diabetic foot syndrome is one of the most frequent complications in type 2 diabetic patients. The present work is carried out with the objective of evaluating the use of DIamel combined with insulin in diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes Mellitus, Type 2
- Trial name
- NCT03583593
- Testing
- DIAMEL
- Where
- Cuba
- Volunteers
- 100 people
- Sponsor
- Catalysis SL
Diabetic Foot Ulcers
A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers
The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers.
- Trial name
- NCT01824407
- Testing
- Electrohydraulic-generated shock wave
- Where
- 19 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- SANUWAVE, Inc.
Venous Leg Ulcer
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.
- Trial name
- NCT04823962
- Testing
- rhGM-CSF + hydrogel, Standard care
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Reponex Pharmaceuticals A/S
Peripheral Arterial Disease, Diabetic Foot
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with…
- Trial name
- DFU-002 (NCT02264288)
- Testing
- PDA-002
- Where
- 45 sites in United States
- Volunteers
- 159 people
- Sponsor
- Celularity Incorporated
Wound, Chronic Leg Ulcer
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are…
- Conditions
- Wound, Chronic Leg Ulcer, Wound Contamination
- Trial name
- NCT03290690
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and…
- Trial name
- CAMPLIFE (NCT06562296)
- Testing
- Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 292 people
- Sponsor
- Cellution Biologics
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
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
Venous Leg Ulcer, Venous Stasis
SkinTE® in the Treatment of Venous Leg Wounds
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings…
- Conditions
- Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer
- Trial name
- NCT03881267
- Testing
- Human Autologous Homologous Skin Construct, Additional Outer Dressing Application, Fibracol Wound Dressing
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- PolarityTE
Diabetic Foot Ulcer (DFU)
A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer
The MARSYAS II study which will be conducted in patients with diabetic foot ulcer (DFU) consists of a Lead-In Phase for safety assessment of multiple doses of the biologic investigational medicinal product (IMP) APO-2 and of a…
- Trial name
- NCT04277598
- Testing
- APO-2
- Where
- 14 sites in Austria, Czechia and 2 more
- Volunteers
- 159 people
- Sponsor
- Aposcience AG
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