| Serena, Thomas |
NCT04457752: Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) |
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| Recruiting | 4 | 124 | US | Dual Layer Amniotic Membrane (DLAM). Artacent® | SerenaGroup, Inc., Tides Medical | Chronic Diabetic Foot Ulcers | 03/22 | 03/23 | | |
| Recruiting | 4 | 292 | US | Amnion-Intermediate-Chorion, AIC, Amnion-Chorion-Amnion, ACA, Standard of Care, SOC | Cellution Biologics, SerenaGroup, Inc., LifeCell | Diabetic Foot Ulcer, Venous Leg Ulcer | 12/26 | 07/27 | | |
NCT03154619: Efficacy of TR 987, Beta-1,3-1,6-D-glucan, in the Treatment of Chronic Venous Insufficiency Ulcers |
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| Active, not recruiting | 2 | 80 | US | 0.1% TR 987, Beta glucan, Placebo gel | SerenaGroup, Inc., TR Therapeutics | Venous Leg Ulcer | 04/19 | 04/21 | | |
| Not yet recruiting | 1 | 40 | NA | NOX1416 plus SOC, ADVANOX, Placebo plus SOC | NOxy Health Products, LLC, SerenaGroup, Inc. | Diabetic Foot Ulcer | 11/25 | 01/26 | | |
| Enrolling by invitation | N/A | 100 | Europe, US | | SerenaGroup, Inc., SerenaGroup Research Foundation | COVID-19 | 05/22 | 05/22 | | |
NCT05687656: Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers |
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| Completed | N/A | 30 | US | InnovaMatrix AC porcine placental ECM therapy | ConvaTec Inc. | Diabetic Foot Ulcer | 01/24 | 01/24 | | |
NCT05291169: Omeza Combination Therapy With Standard of Care to Standard of Care Alone for Chronic Venous Leg Ulcers |
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| Completed | N/A | 54 | US | Omeza® OCM™, Omeza® Complete Matrix, Multimodal Wound Matrix | Omeza, LLC | Venous Leg Ulcer | 11/23 | 03/24 | | |
NCT05608317: A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing |
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| Recruiting | N/A | 20 | US | ALLEVYN Non-Adhesive | Molnlycke Health Care AB | Wounds, Wound of Skin, Wound Leg, Venous Leg Ulcer | 07/24 | 11/24 | | |
NCT05588583: A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. |
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| Recruiting | N/A | 68 | US | Mepilex Up | Molnlycke Health Care AB | Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer | 03/24 | 03/24 | | |
CAMPSTIM, NCT06449638: Modified Platform Trial Assessing Multiple CAMPs and SOC Vs SOC Alone in the Treatment of Hard-to-Heal DFUs |
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| Recruiting | N/A | 272 | US | Standard of Care, Revita, Relese, Cogenex, Enverse | StimLabs, SerenaGroup, Inc. | Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer | 06/26 | 08/26 | | |
CAMPAIGN, NCT06600724: Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs |
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| Recruiting | N/A | 170 | US | Standard of Care, EPIEFFECT, EPIXPRESS | MiMedx Group, Inc., SerenaGroup, Inc. | Diabetic Foot Ulcer, Diabetic Foot, Foot Ulcer Due to Type 2 Diabetes Mellitus, Foot Ulcer, Diabetic, Foot Ulcer | 08/26 | 08/26 | | |
| Completed | N/A | 136 | US | Standard Wound Care Alone, Stand Wound Care plus IPC | Huntleigh Healthcare Ltd, SerenaGroup, Inc. | Venous Leg Ulcer | 03/24 | 03/24 | | |
NCT06606210: INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone |
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| Recruiting | N/A | 120 | US | InnovaMatrix® AC, Porcine Derived Extracellular Matrix | ConvaTec Inc. | Wound Heal, Venous Leg Ulcer | 07/25 | 04/26 | | |
NCT06437028: Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers. |
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| Not yet recruiting | N/A | 170 | NA | Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care | Samaritan Biologics, Serena Group | Diabetic Foot Ulcer | 06/26 | 09/26 | | |
C5CAMP, NCT06674980: Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs |
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| Recruiting | N/A | 177 | US | Standard of Care - DFU, AM/Single - DFU, AM/Double - DFU, Standard of Care - VLU, AM/Single - VLU, AM/Double - VLU | C5 Biomedical, SerenaGroup, Inc. | Pathologic Processes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Disease, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases, Leg Ulcer, Skin Ulcer, Skin Diseases, Diabetes Complications, Diabetic Neuropathies, Foot Diseases, Diabetic Foot, Foot Ulcer, Diabetes Mellitus, Type 2, Ulcer, Foot Ulcer Unhealed | 11/26 | 01/27 | | |
NCT06782386: Remote Temperature and Visual Monitoring to Help Manage Diabetic Foot Ulcers |
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| Not yet recruiting | N/A | 100 | NA | OneStep Foot Scanner | Bluedrop Medical Limited, Serena Group | Diabetic Foot Ulcer (DFU) | 08/26 | 08/26 | | |
| Dhillon, Yadwinder |
NCT04457752: Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) |
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| Recruiting | 4 | 124 | US | Dual Layer Amniotic Membrane (DLAM). Artacent® | SerenaGroup, Inc., Tides Medical | Chronic Diabetic Foot Ulcers | 03/22 | 03/23 | | |
BLADE-VG2, NCT05539963: A Feasibility Trial to Investigate the Safety and Between-group Effect Size of STIMULAN VG and Standard of Care (SoC) in Participants With Diabetic Foot Osteomyelitis |
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| Recruiting | 2 | 60 | US | STIMULAN VG, Systemic Antibiotics | Biocomposites Ltd, MCRA | Diabetic Foot Osteomyelitis | 12/24 | 12/25 | | |
| Recruiting | 2 | 230 | Europe, Canada, US | DBV1605 | DBV Technologies | Cow's Milk Allergy | 03/24 | 03/24 | | |
Mavericks, NCT05758545: Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers |
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| Recruiting | N/A | 450 | US | COMS One device, Concurrent Optical and Magnetic Stimulation, Sham device | Piomic Medical, NAMSA | Diabetic Foot Ulcer | 06/27 | 06/27 | | |
| Walker, Kwadjo |
NCT04457752: Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) |
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| Recruiting | 4 | 124 | US | Dual Layer Amniotic Membrane (DLAM). Artacent® | SerenaGroup, Inc., Tides Medical | Chronic Diabetic Foot Ulcers | 03/22 | 03/23 | | |
