Clinical trials: Chronic Ulcers of the Lower Limb
Venous Leg Ulcer
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
- Trial name
- VIEW-VLU (NCT03257254)
- Testing
- Varithena
- Where
- 14 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Boston Scientific Corporation
Diabetic Foot Ulcers, Venous Stasis Ulcer
Cellular and Tissue Based Therapy Registry
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these…
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Chronic Non Healing Wound
- Trial name
- CTPR (NCT02322554)
- Testing
- Cellular and tissue based products
- Where
- United States
- Volunteers
- 50,000 people
- Sponsor
- U.S. Wound Registry
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer, Non-healing Wound
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks.
- Trial name
- NCT03863054
- Testing
- NATROX™ Topical Oxygen Therapy System
- Where
- Singapore
- Volunteers
- 20 people
- Sponsor
- Singapore General Hospital
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.
Charcot Joint of Foot, Osteoarthropathy
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and…
- Trial name
- CHARQUAM (NCT05491577)
- Testing
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- Where
- 17 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Lower Leg Wound
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
- Trial name
- WoundWand (NCT01924806)
- Testing
- WoundWand™ Debridement Device, Standard of Care sharp debridement
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 11 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Diabetes Mellitus
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat…
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Diabetic Foot, Diabetic Foot Infection
- Trial name
- NCT05610865
- Testing
- Control; Standard-of-care management, Only PRP injection, PRP + SVF injection
- Where
- Pakistan
- Volunteers
- 28 people
- Sponsor
- University of the Punjab
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
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
Diabetic Foot
Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.
- Trial name
- COVER DFUs (NCT05372809)
- Testing
- SkinTE, Control
- Where
- 13 sites in United States
- Volunteers
- 42 people
- Sponsor
- PolarityTE
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
Diabetic Foot Ulcer (DFU), Ocular Disorder
Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application
This prospective interventional clinical study aims to evaluate the safety and therapeutic efficacy of air-dried human amniotic membrane (hAM) sterilized using different doses of gamma irradiation for regenerative medical…
- Conditions
- Diabetic Foot Ulcer (DFU), Ocular Disorder, Pterygium
- Trial name
- GAMMA-AM (NCT07466576)
- Testing
- Air-Dried Human Amniotic Membrane (AD-hAM)
- Where
- Libya
- Volunteers
- 2 people
- Sponsor
- Libyan Center for Biotechnology Research
Chronic Cutaneous Ulcer, Sickle Cell Disease
Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment
Approximately 60 subjects will be enrolled into this double-blind, placebo-controlled study for the Deferoxamine Intradermal Delivery Patch (DIDP).
- Trial name
- D-SCOUT (NCT04058197)
- Testing
- Deferoxamine Product
- Where
- 4 sites in United States
- Sponsor
- TauTona Group
Venous Leg Ulcers
A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects With Venous Leg Ulcers
This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
- Trial name
- NOVEL2 (NCT01199588)
- Testing
- Nexagon® Low Dose, Nexagon® High Dose, Nexagon® Vehicle
- Where
- 34 sites in United States, Australia and 2 more
- Volunteers
- 300 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Chronic Leg Ulcers
Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers
Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate…
- Trial name
- ULCERE (NCT00709631)
- Where
- France
- Volunteers
- 155 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Diabetic Foot Ulcer
The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
- Trial name
- NCT02972528
- Testing
- Platelet Lysate, Platelet Poor Plasma
- Where
- Jordan
- Volunteers
- 30 people
- Sponsor
- Hanan Jafar
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
PAW-Hydrogel for Chronic Wound Healing
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers…
- Conditions
- Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer
- Trial name
- NCT07541196
- Testing
- PAW-Functionalized Carbopol® 940 Hydrogel, Standard Advanced Wound Care
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- Benjamín Gonzalo Rodríguez Méndez
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects.
- Conditions
- Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency, Chronic Venous Disease
- Trial name
- NCT07123285
- Testing
- Photobiomodulation Therapy, Compression Therapy
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- University of Nove de Julho
Venous Leg Ulcer
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).
- Trial name
- NCT03589586
- Testing
- DermACELL AWM
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- LifeNet Health