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Foot Ulcer clinical trials

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NCT ID: NCT04614870 Recruiting - Diabetic Foot Ulcer Clinical Trials

DETEC® Esterase for Screening Wound Infection at Point of Care

Start date: May 1, 2022
Phase:
Study type: Observational

This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during routine wound care. The output of the device is correlated with clinical determination of infection to assess the device efficacy in identifying presumptive infections.

NCT ID: NCT04614038 Recruiting - Diabetic Foot Ulcer Clinical Trials

DETEC® pH Point of Care Wound Diagnostic Test

Start date: January 1, 2022
Phase:
Study type: Observational

The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds. It is hypothesized that wounds with an alkaline environment as indicated by DETEC pH will have a high chance of not healing over 12 weeks of wound care.

NCT ID: NCT04591691 Recruiting - Diabetes Clinical Trials

C-myc Biomarker Study for Diabetic Foot Ulcers

Start date: October 14, 2020
Phase:
Study type: Observational

This is a multi-center observational cohort study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict complete wound healing. Eligible and consented participants will begin standard of care treatment after collection of tissue specimens from the wound's edge. An additional tissue specimen is collected at 4 weeks if clinically indicated. Tissues will be tested for c-myc and phosphorylated glucocorticoid receptor (p-GR) levels using validated protocols at a central laboratory. Participants will be followed weekly for up to 12 weeks or until complete wound healing (whichever occurs first). One final assessment 2 weeks after complete wound healing will occur to confirm healing.

NCT ID: NCT04569409 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Wagner Grade 2 Foot Ulcers.

Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Wagner grade 2 Foot Ulcer, compared to placebo therapy.

NCT ID: NCT04564443 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot

Start date: September 11, 2020
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.

NCT ID: NCT04533152 Recruiting - Diabetic Foot Ulcer Clinical Trials

Prognostic Determinants in Patients With Diabetic Foot Ulcer.

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Start date: November 24, 2021
Phase:
Study type: Observational

The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease. The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.

NCT ID: NCT04497805 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

Start date: September 8, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.

NCT ID: NCT04464213 Recruiting - Diabetic Foot Ulcer Clinical Trials

Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer

Start date: November 1, 2020
Phase: Phase 1
Study type: Interventional

This study is designated to: 1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer. 2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. 3. study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.

NCT ID: NCT04460573 Recruiting - Diabetic Foot Ulcer Clinical Trials

Smart Boot Use to Measure Offloading Adherence

Start date: October 19, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

NCT ID: NCT04457752 Recruiting - Clinical trials for Chronic Diabetic Foot Ulcers

Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)

Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial. Study is estimated to require 12 months from first subject enrolled to last subject visit.