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Diabetic Foot clinical trials

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NCT ID: NCT04716790 Recruiting - Diabetic Foot Ulcer Clinical Trials

Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).

Start date: April 20, 2021
Phase: N/A
Study type: Interventional

The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.

NCT ID: NCT04714411 Recruiting - Clinical trials for Diabetic Foot Infection

Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis

Start date: November 5, 2020
Phase:
Study type: Observational

This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020). Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI [E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)], including subjects with AOM [M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.

NCT ID: NCT04709887 Recruiting - Diabetic Foot Clinical Trials

Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.

NCT ID: NCT04689425 Recruiting - Diabetic Foot Ulcer Clinical Trials

Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer

DFU-MNC
Start date: March 30, 2021
Phase: Phase 3
Study type: Interventional

Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

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.