Clinical trials: Diabetic Foot Ulcer (DFU)
Diabetic Foot Ulcer, Venous Leg Ulcer
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Ulcer Foot, Leg Ulcer
- Trial name
- NCT06560502
- Testing
- Standard of Care-DFU, AmnioCore - DFU, Amnio Quad-Core - DFU
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Stability Biologics
Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic
Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
- Conditions
- Diabetic Foot Ulcers (DFU), Foot Ulcer Chronic, Ulcer, Diabetic Foot Ulcer
- Trial name
- SCANX (NCT07360418)
- Testing
- Blue Drop Foot Scanner
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Applied Biologics, LLC
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
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds
This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.
- Conditions
- Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
- Trial name
- NCT07078968
- Testing
- Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- BioLab Holdings
Diabetic Foot Ulcer
Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs.
- Trial name
- DFUs (NCT03855514)
- Testing
- NuShield
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Diabetic Foot Disease, Diabetic Foot Infection
Effect of a Coordinated Primary-care-Based MDT-model on the Treatment of Hard-to-heal Ulcers
The TSS project is a study of the effects of treating hard-to-heal ulcers in a multidisciplinary cross sectional team, meaning that nurse and doctor from a hospital based wound healing clinic and wound care nurse from the primary…
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Ulcer (DFU), Ulcer
- Trial name
- TSS (NCT07747896)
- Testing
- coordinated primary-care-based MDT-model, Standard Care (in control arm)
- Where
- Denmark
- Volunteers
- 80 people
- Sponsor
- Nordsjaellands Hospital
Diabetic Foot Ulcer
A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.
- Trial name
- NCT03078933
- Testing
- Standard of Care, Nitric Oxide Therapy 2x week 6 min. plus standard of care, Nitric Oxide Therapy 2x week 12 min. plus standard of care
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Origin Inc.
Diabetic Foot Ulcer
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic…
- Trial name
- NCT04723134
- Testing
- Folinic acid calcium salt
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Joseph Boykin, MD
Diabetic Foot Ulcer (DFU)
A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs
The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in…
- Trial name
- NCT07116174
- Testing
- Xcell Amnio Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 135 people
- Sponsor
- New Horizon Medical Solutions
Pathologic Processes, Diabetes Mellitus
Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs
The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers…
- Conditions
- Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases
- Trial name
- C5CAMP (NCT06674980)
- Testing
- Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- C5 Biomedical
Diabetic Foot Ulcer, Wagner Grade 1 - 2
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the…
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Trial name
- NCT07396376
- Testing
- ELU42 Topical Spray
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Eluciderm Inc
Diabetic Foot Ulcers
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care.
- Trial name
- DUNE (NCT01490879)
- Testing
- Nexagon® Low Dose, Nexagon® Medium Dose, Nexagon® High Dose
- Where
- 25 sites in United States, Russia and 1 more
- Volunteers
- 168 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Diabetic Foot Ulcer, DFU
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks…
- Conditions
- Diabetic Foot Ulcer, DFU, Diabetic Foot Ulcer (DFU), Foot Ulcer Due to Type 1 Diabetes Mellitus
- Trial name
- RENEW (NCT07086443)
- Testing
- Activate™ Matrix, AmnioDefend™ FT Matrix, Palisade™ DM Matrix
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Sequence LifeScience, 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 Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
- Trial name
- NCT03183726
- Testing
- ALLO-ASC-DFU
- Volunteers
- 4 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer (DFU), Ulcer Foot
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving…
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Trial name
- CAMPSTIM (NCT06449638)
- Testing
- Standard of Care, Revita, Relese
- Where
- 5 sites in United States
- Volunteers
- 272 people
- Sponsor
- StimLabs
Diabetic Foot Ulcer
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period.
- Trial name
- DFUMAT (NCT05968924)
- Testing
- Podimetrics SmartMat
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Diabetic Foot Ulcers, Osteomyelitis
UT Southwestern Diabetic Foot Ulcers (DFU) and Osteomyelitis (DFO) Recruitment Database, Data and Tissue Repository
This will be a continuing, prospective study of diabetic foot ulcers and infections, risk factors and clinical outcomes and a limited data set conducted by the investigator through the establishment of a data and tissue…
- Trial name
- DFUDatabase (NCT02463500)
- Testing
- DFU
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- University of Texas Southwestern Medical Center
Diabetic Foot Ulcers (DFU)
Evaluation of Left Ventricular Function After Treatment of Diabetic Foot Ulcers Using Longitudinal Strain Echocardiography
Early detection of heart failure as a macrovascular complication of DM offers the best chance of cure in these patients. Nowadays, the most common method for detecting heart failure is measuring left ventricle ejection fraction…
- Trial name
- NCT06747377
- Volunteers
- 52 people
- Sponsor
- Assiut University
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