Clinical trials: Lower Extremity Ulcer
Diabetic Foot Ulcer
Study of Oasis Ultra in Diabetic Foot Ulcers
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.
- Trial name
- NCT01835379
- Testing
- Oasis, Standard
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Healthpoint
Venous Ulcer of Leg
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will…
- Trial name
- IGuideU (NCT04696354)
- Testing
- IVUS, Continued Compression Therapy/Stockings
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Venous Leg Ulcer, Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
- Trial name
- NCT02395302
- Testing
- Dual Action Pneumatic Compression
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Tactile Medical
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-1 (NCT02427802)
- Testing
- Gentamicin collagen sponge
- Where
- 86 sites in United States
- Volunteers
- 612 people
- Sponsor
- Innocoll
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
Diabetic Foot Ulcers
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers.
- Trial name
- NCT01454401
- Testing
- LeucoPatch treatment
- Where
- 7 sites in Denmark, Sweden
- Volunteers
- 60 people
- Sponsor
- Reapplix
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
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
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
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.
Bacterial Infections, Diabetic Foot
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
- Conditions
- Bacterial Infections, Diabetic Foot, Osteomyelitis
- Trial name
- NCT00366249
- Testing
- Tigecycline, Ertapenem
- Where
- 211 sites in United States, Argentina and 37 more
- Volunteers
- 1,061 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Diabetic Foot Ulcer, Diabetes Mellitus, Type 2
Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers
People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months.
- Trial name
- NCT03002155
- Testing
- EnhanceFitness community exercise program
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Washington
Diabetic Foot Ulcer
Characterization of AmnioExcel Plus in Two Treatment Paradigms
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+.
- Trial name
- NCT04233580
- Testing
- Amnio Excel + weekly, Amnio Excel + max every 2 weeks
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcer, Deep Diabetic Foot Ulcer
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
Diabetes-related foot ulcers (DFUs) are a leading cause of hospitalization and amputation worldwide, and account for 33% of all direct costs of diabetes care in the US.
- Trial name
- NCT03476876
- Testing
- Dermacell, Integra
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Baylor College of Medicine
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
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
Diabetes, PAD
Micro-mobile Foot Compression and Diabetic Foot
Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected.
- Conditions
- Diabetes, PAD, Lower Extremity Edema, Neuropathy;Peripheral
- Trial name
- NCT03135535
- Testing
- Avex Footbeat
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcer
GrafixPL PRIME Evaluation Case Study
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL…
- Trial name
- NCT03742440
- Testing
- GrafixPL PRIME
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcer, Offloading
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected.
- Trial name
- NCT02783066
- Testing
- Offloading boot: PulseFlow
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited