Clinical trials: Ulcer, Leg
Diabetic Foot
Less Infections for the Diabetic Foot
This is a randomized, unblinded, single-centre study. After eventual surgical debridement (not amputation), patients will be randomized to receive 1 of 2 targeted antibiotic regimens, in the ratio 1:1.
- Trial name
- NCT03615807
- Testing
- Surgical debridement (if needed), Microbiological sampling, Revascularisation (if needed).
- Where
- Switzerland
- Volunteers
- 182 people
- Sponsor
- University Hospital, Geneva
Venous Disease
Perforator Vein Injection for Symptomatic Venous Disease
The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs.
- Trial name
- Dillavou (NCT03363633)
- Testing
- sodium tetradecyl sulfate, Compression
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ellen Dillavou
Neuropathic Diabetic Ulcer - Foot
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus…
- Trial name
- NCT01060670
- Testing
- Integra® Dermal Regeneration Template, Conventional Wound Therapy
- Where
- 33 sites in United States, Netherlands Antilles
- Volunteers
- 545 people
- Sponsor
- Integra LifeSciences Corporation
Venous Stasis Ulcers
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
- Trial name
- SSVS (NCT00832091)
- Testing
- Thymosin Beta 4
- Where
- 8 sites in Italy, Poland
- Volunteers
- 72 people
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
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
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Diabetic Foot Ulcer, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Venous Leg Ulcer, Venous Stasis Ulcers
Dose Finding Study of HP802-247 in Venous Leg Ulcers
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together…
- Trial name
- NCT00852995
- Testing
- HP802-247
- Where
- 30 sites in United States, Canada
- Volunteers
- 228 people
- Sponsor
- Healthpoint
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot Ulcer, Diabetes Mellitus
CSTC1 for Diabetic Foot Ulcers Phase II Study
The objective of this study is to evaluate the efficacy and safety of CSTC1 in patient with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Wounds
- Trial name
- NCT01813305
- Testing
- CSTC1, CSTC1 Matched vehicle
- Where
- Taiwan
- Volunteers
- 124 people
- Sponsor
- Charsire Biotechnology Corp.
Diabetes
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
- Trial name
- NCT02211495
- Testing
- GEKO device, Best Medical Therapy
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
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.
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC
Diabetic Foot Ulcer
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
- Trial name
- NCT06557122
- Testing
- SOC and Advanced Bioengineered Skin Substitute, SOC and Active Comparator
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Encoll Corp
Diabetic Foot Ulcer
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
- Trial name
- NCT03998436
- Testing
- Esmolol Hydrochloride, Only Standard of Care, Vehicle Gel
- Where
- 14 sites in India
- Volunteers
- 176 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Diabetic Neuropathies
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment in People With Diabetic Neuropathy
The main objective of this trial is to investigate the effect of an educational booklet foot-related exercise in diabetic neuropathy status, functional outcomes and gait biomechanics in people with diabetic neuropathy.
- Trial name
- FOCA-II (NCT04008745)
- Testing
- Educational and home-based physical therapy by foot-related exercises
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- University of Sao Paulo General Hospital
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.