Clinical trials: Foot Care
Wound Heal, Ulcer
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Trial name
- IDEAL (NCT06616844)
- Testing
- InnovaMatrix® AC
- Where
- 21 sites in United States
- Volunteers
- 235 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC
Diabetic Foot Ulcer
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
- Trial name
- NCT06557122
- Testing
- SOC and Advanced Bioengineered Skin Substitute, SOC and Active Comparator
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Encoll Corp
Diabetic Foot Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537016
- Testing
- PROMOGRAN, Tielle
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
Diabetic Foot, Diabetic Foot Ulcer
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Trial name
- NCT06035536
- Testing
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Where
- 11 sites in United States
- Volunteers
- 143 people
- Sponsor
- Aroa Biosurgery Limited
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 Ulcer
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
- Trial name
- NCT00387101
- Testing
- Dermal - Living Skin Replacement (Dermal - LSR)
- Where
- 12 sites in United States
- Volunteers
- 288 people
- Sponsor
- ApoPharma
Diabetic Foot Ulcer (DFU)
Askina Calgitrol Paste Diabetic Foot Ulcers
The purpose of this study is to assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.
- Trial name
- NCT01912092
- Testing
- Askina Calgitrol paste
- Where
- 2 sites in Italy
- Volunteers
- 22 people
- Sponsor
- BBraun Medical SAS
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 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
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 Ulcers, Foot Wounds
Santyl vs. Sharp Debridement of Diabetic Foot Wounds
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
- Trial name
- NCT01056198
- Testing
- Santyl, Control
- Where
- 9 sites in United States
- Volunteers
- 48 people
- Sponsor
- Healthpoint
Diabete Mellitus, Foot Ulcer Chronic
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
- Trial name
- NCT07326553
- Testing
- Placental Membrane
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- BioXTek
Foot Ulcer, Diabetic
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
- Trial name
- NCT01858545
- Testing
- MatriStem, Cellular Dermal Replacement Tissue
- Where
- 9 sites in United States
- Volunteers
- 56 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcers
Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft. The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to…
- Trial name
- NCT02707406
- Testing
- NEOX®CORD 1K, standard of care
- Where
- 22 sites in United States, Canada
- Volunteers
- 124 people
- Sponsor
- BioTissue Holdings, Inc
Diabetic Foot Ulcer
Prospective, Multicenter, RCT of the Tenex Ultrasound System
The goal of this multicenter randomized controlled trial is compare standard of care (SOC) to Tenex MicroTip ultrasound therapy plus SOC in patients with Wagner 1-2 diabetic foot ulcers.
- Trial name
- NCT06137222
- Testing
- Tenex TXB MicroTip Ultrasound system plus SOC, Standard of Care for diabetic foot ulcer
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Tenex Health Inc.
Diabetic Foot Ulcers
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a…
- Trial name
- STRIDE 2 (NCT01849965)
- Testing
- DSC127, Standard of Care gel, Aquasite
- Where
- 56 sites in United States, Canada and 2 more
- Volunteers
- 396 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer, Pressure Injury
Evaluating Clinical Acceptance of a NPWT Wound Care System
Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- Trial name
- NCT03670225
- Testing
- Invia Motion Endure
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medela AG
Diabetic Foot Ulcers (DFUs)
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC.
- Trial name
- NCT06767501
- Testing
- E-GRAFT ™, FIBRACOL™
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Skye Biologics Holdings, LLC