Clinical trials: Leg Ulcer
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Varicose Ulcer
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.
- Trial name
- MOJITO (NCT01998932)
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Diabetic Foot Ulcers, Diabetic Foot Wounds
Using Santyl on Diabetic Foot Ulcers
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound.
- Trial name
- NCT01408277
- Testing
- Santyl, Control
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Healthpoint
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
Venous Thrombosis
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity.
- Trial name
- NCT01406795
- Testing
- Gore Viabahn Heparin Coated Stent
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stanford University
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Chronic Ulcer of Lower Extremity
Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol
Wound healing rate is higher when contact ultrasound therapy is followed by noncontact ultrasound therapy on sub-acute and chronic lower extremity ulcers of various etiologies requiring selective debridement, as compared to…
- Trial name
- NCT02045303
- Testing
- Contact Ultrasound Therapy, Noncontact Ultrasound Therapy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Texas Health Resources
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
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
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.
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
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally…
- Trial name
- NCT00764361
- Testing
- doxycycline
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NanoSHIFT LLC
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
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.
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 Ulcers, Foot Wounds
Santyl vs. Sharp Debridement of Diabetic Foot Wounds
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
- Trial name
- NCT01056198
- Testing
- Santyl, Control
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Healthpoint
Foot Ulcer, Diabetic
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
- Trial name
- NCT01013792
- Testing
- Wound Dressing
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Solventum US LLC
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-2 (NCT02447172)
- Testing
- Gentamicin Collagen sponge
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 524 people
- Sponsor
- Innocoll