Clinical trials: Diabetic Foot Ulcers (DFUs)
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
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
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
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 Ulcer
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
- Trial name
- NCT04133493
- Testing
- Kerecis Omega3 Wound, Fibracol
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kerecis Ltd.
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 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, 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
Diabetic Foot Ulcer (DFU)
High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and…
- Trial name
- NCT06470087
- Testing
- SOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
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 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
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 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, Chronic Ulcer
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
- Trial name
- NCT04185558
- Testing
- ActiGraft, Standard of Care
- Where
- 16 sites in United States, South Africa and 1 more
- Volunteers
- 119 people
- Sponsor
- RedDress Ltd.
Diabetic Foot
SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
- Trial name
- NCT06140303
- Testing
- SkinTE, Control
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- PolarityTE
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.
Diabetic Foot Ulcers (DFUs)
Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.
- Trial name
- NCT07185048
- Testing
- Conventional Foot Care Control Group, Digital Foot Care (Low-Intensity), Digital Foot Care (Moderate-Intensity)
- Volunteers
- 1,512 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
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
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