Clinical trials: Foot Ulcer, Diabetic
Diabetic Foot Ulcer
Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.
- Trial name
- NCT02967900
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Michelson Diagnostics Ltd.
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
Foot Ulcer, Diabetic
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
- Trial name
- NCT00516958
- Testing
- Topical Dermacyn, Topical Dermacyn and Levofloxacin, Topical Saline and Levofloxacin
- Where
- 16 sites in United States
- Volunteers
- 65 people
- Sponsor
- Oculus Innovative Sciences, Inc.
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.
- Trial name
- NCT06383013
- Testing
- BB-101
- Where
- 5 sites in Taiwan
- Volunteers
- 96 people
- Sponsor
- Blue Blood Biotech Corp.
Diabetic Foot Ulcer
TWB-103 for Treating Lower Limb Ulcers on Patients With DM
Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers
- Trial name
- NCT03624023
- Testing
- TWB-103
- Where
- 2 sites in Taiwan
- Volunteers
- 10 people
- Sponsor
- Transwell Biotech Co., Ltd.
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Diabetic Neuropathies, Diabetic Foot
Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
The goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in the refinement of a system designed to…
- Conditions
- Diabetic Neuropathies, Diabetic Foot, Diabetic Retinopathy
- Trial name
- NCT03069729
- Testing
- no intervention
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- VisionQuest Biomedical LLC
Foot Ulcer, Diabetic
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
- Trial name
- NCT01228500
- Testing
- PriMatrix
- Where
- United States
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot
Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old…
- Trial name
- MATRIX (NCT00493051)
- Testing
- GAM501, Standard of care
- Where
- 29 sites in United States
- Volunteers
- 124 people
- Sponsor
- Tissue Repair Company
Diabetic Foot Ulcer
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral…
- Trial name
- NCT00593567
- Testing
- gentamicin-collagen sponge, Levofloxacin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Innocoll
Diabetic Foot, Varicose Ulcer
Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers
The purpose of this study is to compare the VERSAJET™ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers.
- Conditions
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
- Trial name
- NCT00521027
- Testing
- Versajet Hydrosurgery System, Conventional surgical debridement techniques
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcers
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT00432965
- Testing
- Moist Wound Therapy, VAC Therapy
- Where
- 25 sites in United States, Canada
- Volunteers
- 335 people
- Sponsor
- KCI USA, 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.
Pressure Ulcer
PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers. To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular…
- Trial name
- PRELINEM (NCT05763654)
- Testing
- Linovera emulsion
- Where
- Spain
- Volunteers
- 164 people
- Sponsor
- B. Braun Medical SA
Diabetic Foot Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
A Prospective Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AC
This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amnion Chorion (BR-AC) plus standard of care versus standard of care only in the treatment of diabetic foot…
- Trial name
- NCT06511596
- Testing
- BR-AC, Standard Care
- Where
- 11 sites in United States
- Volunteers
- 71 people
- Sponsor
- BioStem Technologies
Diabetic Foot Ulcers
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
- Trial name
- NCT01154374
- Testing
- MEBO Wound Ointment, Standard of Care (sterile saline moistened gauze)
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Skingenix, Inc.
Diabetic Foot Ulcer
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers.
- Trial name
- TriO FITT (NCT06003400)
- Testing
- Study treatment administration (TriO FITT), Physical Examination, Vital Signs
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Tri.O Medical LTD
Staphylococcal Skin Infections
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
- Trial name
- NCT00463801
- Testing
- Daptomycin
- Where
- 2 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Novartis