Clinical trials: Lower Extremity Ulcer
Venous Leg Ulcer
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox…
- Trial name
- Granulox01 (NCT04181320)
- Testing
- Venous Leg Ulcer Standard of Care with Granulox
- Where
- 27 sites in Croatia, Czechia and 5 more
- Volunteers
- 128 people
- Sponsor
- Molnlycke Health Care AB
Sickle Cell Disease
Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
The investigators are conducting a Phase II prospective and placebo controlled study of a topical cream containing sodium nitrite compared to the current standard of care.
- Trial name
- NCT02863068
- Testing
- Topical Sodium Nitrite
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- caterina P minniti
Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer
Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds
Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of…
- Conditions
- Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03182582
- Testing
- Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Scalpel/Curette Debridement
- Volunteers
- 22 people
- Sponsor
- Stanford University
Diabetic Foot
Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment
Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma…
- Trial name
- NCT01199783
- Testing
- Daptomycin, Vancomycin
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Ruhr University of Bochum
Diabetic Foot Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
- Trial name
- FEENICS (NCT00662831)
- Testing
- Fragmin/ Dalteparin Sodium
- Where
- 63 sites in Austria, Belgium and 15 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Diabetic Foot Ulcers
Negative Pressure Wound Therapy as a Drug Delivery System
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous…
- Trial name
- NCT02463487
- Testing
- Cardinal Pro +Simultaneous Irrigation (NPWTi), Cardinal Pro (NPWT) Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Texas Southwestern Medical Center
Venous Leg Ulcer
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control saline irrigation solution and…
- Trial name
- NCT01153633
- Testing
- Prontosan Wound Irrigation Solution and Prontosan Wound Gel
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Diabetic Foot Ulcers, Wound
Topical Oxygen Therapy for Diabetic Wounds
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial.
- Trial name
- NCT02313428
- Testing
- Topical Oxygen Chamber for Extremities
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
Venous Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Ulcers, Wounds
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
- Trial name
- NCT00951080
- Testing
- Traditional NPWT System, SNaP Wound Care System
- Where
- 17 sites in United States
- Volunteers
- 132 people
- Sponsor
- 3M
Venous Hypertension Ulcers, Venous Stasis Ulcer
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency
- Trial name
- MUSTCOOL (NCT02626156)
- Testing
- Cooling gel pack, Cooling cotton pack
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medical University of South Carolina
Venous Ulcer
Flexitouch Treatment for Venous Ulcers
This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers.
- Trial name
- NCT00847002
- Testing
- Standard Wound Care, Flexitouch System with Standard Wound Care
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tactile Systems Technology, Inc.
Diabetes, Diabetic Foot Ulcer
Electrical Stimulation to Accelerate Wound Healing
A clinical study at the Baylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy, is being proposed to test the efficacy of a novel electrical stimulation platform named the Tennant Biomodulator designed…
- Conditions
- Diabetes, Diabetic Foot Ulcer, Peripheral Neuropathy, Peripheral Arterial Disease
- Trial name
- NCT03821675
- Testing
- Electrical Stimulation - Active
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Foot Ulcer, Diabetic
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
- Trial name
- NCT01858545
- Testing
- MatriStem, Cellular Dermal Replacement Tissue
- Where
- 9 sites in United States
- Volunteers
- 56 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Neuropathies
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
- Trial name
- NCT02790931
- Testing
- Intervention Group
- Where
- Brazil
- Volunteers
- 78 people
- Sponsor
- University of Sao Paulo General Hospital
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
Pressure Ulcer, Soft Tissue Necrosis Lower Limb
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.
- Trial name
- NCT01208220
- Testing
- Negative Pressure Wound Therapy, Collagenase Ointment
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center Shreveport
Foot Ulcer, Diabetic, Diabetic Foot
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
- Trial name
- NCT00796744
- Testing
- NorLeu3-A(1-7) in a gel formulation
- Where
- 12 sites in United States
- Volunteers
- 78 people
- Sponsor
- US Biotest, Inc.