Clinical trials: Diabetic Foot Ulcers (DFUs)
Diabetic Foot Ulcers (DFUs)
Effect of Meso Wound Matrix in the Treatment of DFUs
This is a prospective trial designed to evaluate the use of Meso Wound Matrix (DSM Biomedical, Exton, PA) in Wagner grade 1 and 2 DFUs.
- Trial name
- NCT04182451
- Testing
- Meso Wound Matrix
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- SerenaGroup, Inc.
Diabetic Foot Ulcer, Diabetic Foot
Adapting Lifestyle Offloading for DFUs
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care.
- Trial name
- NCT06278935
- Testing
- Lifestyle-based intervention by an occupational therapist
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Southern California
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer
Evaluation of AUP12602-C as New Topical Treatment for DFUs (DIAMEND STUDY)
This is a phase 2 study performed in diabetic foot ulcer (DFU) patients with chronic non-healing, neuro-ischemic wounds to investigate the safety, tolerability and efficacy of AUP1602-C.
- Trial name
- NCT06111183
- Testing
- AUP1602-C
- Where
- 10 sites in Germany, Italy and 1 more
- Volunteers
- 64 people
- Sponsor
- Aurealis Oy
Diabetic Foot Ulcer, Diabetic Foot Infection
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.
- Trial name
- NM2023 (NCT06667752)
- Testing
- Advanced Antibacterial Wound Dressing, Aquacel Ag+ Extra
- Where
- 11 sites in Estonia, Spain
- Volunteers
- 136 people
- Sponsor
- Nanordica Medical OU
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- Trial name
- CAMP RWE (NCT07046767)
- Testing
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap, IP2: BioLab Tri-Membrane Wrap
- Where
- 7 sites in United States
- Volunteers
- 165 people
- Sponsor
- Capsicure, LLC
Diabetic Foot Ulcers
A Randomized,Double-blind,Placebo-controlled Clinical Study to Explore the Mechanism of Action of ON101 Cream in Patients With DFUs.
The primary objective is to explore the mechanistic role of ON101 cream in healing diabetic foot ulcers by determining the molecular targets of ON101 cream.
- Trial name
- NCT04945161
- Testing
- ON101 Cream
- Where
- Taiwan
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer (DFU)
Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .
Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities.
- Trial name
- ACGR (NCT06725238)
- Testing
- Acute-to-chronic glycemic ratio
- Where
- Iraq
- Volunteers
- 80 people
- Sponsor
- University of Diyala
Diabetic Foot, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
Wound, Foot, Diabetic Foot Ulcer (DFU)
CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs
CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to…
- Conditions
- Wound, Foot, Diabetic Foot Ulcer (DFU), Venus Leg Ulcer
- Trial name
- CAMPR-II (NCT07701590)
- Testing
- Microlyte®, IP 1: Membrane Wrap - Hydro
- Where
- 7 sites in United States
- Volunteers
- 147 people
- Sponsor
- Capsicure, LLC
Diabetic Foot, Diabetic Foot Ulcer
Environmental Factors on DFUs Incidence - a Mixed-mode Survey
Diabetic foot ulcers (DFUs) pose a significant threat to the health and wellbeing of diabetic patients. Affecting around 1 in 10 people (NHS North West Coast Strategic Clinical Networks, 2017) regardless of a diabetes type they…
- Trial name
- NCT05464524
- Testing
- Main questionnaire, Optional 12-week follow up questionnaire
- Where
- United Kingdom
- Volunteers
- 179 people
- Sponsor
- King's College London
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
Diabetic Foot Ulcers (DFUs), Diabetic Foot
Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds
- Trial name
- FOCUS 3D (NCT07632001)
- Testing
- Miro3D Wound Matrix, Standard of Care
- Where
- 14 sites in United States
- Volunteers
- 180 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcers (DFUs)
PREPUP: A Randomized Trial of Bonvadis® Versus Collagenase Ointment in Diabetic Foot Ulcers
This study is designed to evaluate topical wound products for DFUs using a hybrid design that combines prospectively randomized treatment arms with external control cohorts.
- Trial name
- NCT07779239
- Testing
- Bonvadis® (NWBOT), Clostridial Collagenase Ointment
- Where
- 10 sites in United States
- Volunteers
- 100 people
- Sponsor
- Oneness Biotech Co., Ltd.
Diabetic Foot Ulcer (DFU), Ulcer Foot
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in…
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Trial name
- CORDSTIM-DFU (NCT07449975)
- Testing
- Standard of Care (SOC), Corplex P, Theracor
- Volunteers
- 272 people
- Sponsor
- StimLabs
Diabetic Foot Ulcers (DFUs)
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3.
- Trial name
- NCT07565506
- Testing
- Antimicrobial agent
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Lakewood-Amedex Inc
Non Healing Diabetic Foot Ulcer
Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of Care
This is a 12 week, randomized controlled trial. There are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm.
- Trial name
- WAR (NCT04207099)
- Testing
- MolecuLight i:X Imaging Device
- Where
- 3 sites in United States
- Volunteers
- 61 people
- Sponsor
- MolecuLight Inc.
Diabetic Foot
Clinical Trial Evaluating a Hyaluronic Acid Matrix in the Treatment of Chronic Non-healing Diabetic Foot Ulcers (DFUs)
This study is a multi-center, prospective trial designed to evaluate the use of HaM in Wagner grade 1 and 2 DFUs. After screening, subjects are treated with weekly application of HaM and SOC for 8 weeks followed by SOC alone for…
- Trial name
- NCT05198544
- Testing
- Hēlaquis Matrix is a hyaluronic acid matrix (HaM)
- Volunteers
- 15 people
- Sponsor
- SerenaGroup, Inc.
Diabetic Foot Ulcer
Efficacy of ProgenaMatrix™ in the Management of DFUs
This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.
- Trial name
- NCT06292026
- Testing
- ProgenaMatrix Keratin graft, standard of care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- ProgenaCare Global, LLC
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