Clinical trials: Chronic Ulcer of Lower Extremity
Chronic Leg Ulcer
Oxygen Wound Therapy Feasibility Study
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
- Trial name
- NCT05422248
- Testing
- Series Topical Oxygen Therapy, Paired Topical Oxygen Therapy
- Where
- New Zealand
- Volunteers
- 10 people
- Sponsor
- Fisher and Paykel Healthcare
Ulcer, Leg Ulcer
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.
- Conditions
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes
- Trial name
- NCT02973893
- Testing
- VF001-DP LD, VF001-DP HD
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- Factor Therapeutics Ltd.
Diabetic Foot Ulcer (DFU), Amnio-Maxx
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Trial name
- NCT07209475
- Testing
- Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care (Investigator Choice)
- Where
- 8 sites in United States
- Volunteers
- 248 people
- Sponsor
- Royal Biologics
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, 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
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
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
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
Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous…
- Trial name
- NCT02015221
- Testing
- Dual Action Pneumatic Compression Device, Standard Compression Garments
- Where
- 11 sites in United States
- Volunteers
- 81 people
- Sponsor
- Tactile Medical
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
Wound Heal, Diabetic Foot Ulcer
Acellular Dermal Allograft for Chronic Diabetic Wounds
The purpose of this study is to determine the efficacy of a novel decellularized dermal matrix (DDM) DermGEN™ for the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT06227520
- Testing
- decellularized dermal matrix
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto
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