Clinical trials: Leg Ulcer
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
Diabetic Foot, Diabetic Ulcer of Left Foot
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban…
- Conditions
- Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
- Trial name
- NCT05203471
- Testing
- integrated care model
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- University of Wisconsin, Madison
Diabetic Foot, Peripheral Arterial Disease
TEsting for Arterial Disease in Diabetes (TrEAD) Study
This study will focus on determining; How accurate the test is in detecting poor circulation How it's accuracy compares to other commonly used tests, and Whether test results are linked to the chance of ulcer healing or…
- Conditions
- Diabetic Foot, Peripheral Arterial Disease, Diabetic Foot Ulcer, Peripheral Vascular Diseases
- Trial name
- NCT04058626
- Testing
- Transcutaneous pressure of oxygen (TcPO2), Toe Brachial Pressure Index (TBPI), Podiatry Ankle Duplex scan (PAD-scan)
- Where
- 2 sites in United Kingdom
- Volunteers
- 305 people
- Sponsor
- Imperial College Healthcare NHS Trust
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
Diabetes Mellitus, Diabetic Neuropathies
Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures
The purpose of this study is to examine the effectiveness of a novel patient education strategy, compared to a standard diabetic foot education.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies, Foot Complications
- Trial name
- DFE (NCT01941719)
- Testing
- Enhanced foot care education, Standard Foot Care Education
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Temple University
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer
CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
- Trial name
- DULCIS (NCT02677779)
- Testing
- CO2 laser, traditional surgery
- Volunteers
- 20 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Varicose Veins, Venous Stasis
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins…
- Conditions
- Varicose Veins, Venous Stasis, Venous Insufficiency
- Trial name
- DESIVI (NCT03850496)
- Testing
- Revitive IX Neuromuscular Stimulation Device
- Volunteers
- 76 people
- Sponsor
- Imperial College London
Diabetic Foot Ulcer
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
- Trial name
- NCT01951768
- Testing
- Garamycin Sponge (Gentamicin-Collagen sponge), Systemic Antibiotic
- Where
- Switzerland
- Volunteers
- 88 people
- Sponsor
- University Hospital, Geneva
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcers, Pressure Ulcers
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
- Trial name
- NCT00971048
- Testing
- HP828-101, Hydrogel/Hydrocolloid
- Where
- 11 sites in United States
- Volunteers
- 88 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human…
- Trial name
- NCT04918784
- Testing
- Restrata®, Wound Dressing
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Acera Surgical, Inc.
Venous Leg Ulcer, Mixed Leg Ulcer
Leg Ulcers Standards of Care Enhancement
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients…
- Trial name
- LUCE (NCT04689009)
- Testing
- EmoLED, current Standards Of Care
- Where
- 5 sites in Italy
- Volunteers
- 83 people
- Sponsor
- Emoled
Leg Ulcers
Biatain Ag vs Biatain in the Treament of Leg Ulcers
the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers…
- Trial name
- NCT00807664
- Testing
- Biatain Ag, Biatain
- Volunteers
- 182 people
- Sponsor
- Coloplast A/S
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 Ulcer
Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers
The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which…
- Trial name
- COMPARACHILLE (NCT04046120)
- Testing
- Heel-free bandage
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Nantes University Hospital
Venous Leg Ulcers
A RCT Evaluating Efficacy of Type-I Collagen Skin Substitute vs. Human Amnion Membrane in Treatment of Venous Leg Ulcers
Venous leg ulcers are chronic wounds caused by venous insufficiency, leading to significant morbidity. The purpose of this randomized, controlled study is to evaluate the safety and efficacy of the application of Type-I…
- Trial name
- NCT06831760
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Dr Naveen Narayan MS, MCh (Plastic Surgery)
Diabetic Foot Ulcer, Diabetic Foot
Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer
In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes.
- Trial name
- NCT01844479
- Testing
- diabetic foot orthotic, Standard innersole
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Michigan
Diabetic Foot Ulcer
PriMatrix for the Management of Diabetic Foot Ulcers
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment.
- Trial name
- NCT03010319
- Testing
- PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device
- Where
- 17 sites in United States
- Volunteers
- 226 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
Preventing Diabetic Foot Ulcers Through Cleaner Feet
Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes.
- Trial name
- NCT03503370
- Testing
- Chlorhexidine
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- VA Office of Research and Development