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Foot Ulcer clinical trials

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NCT ID: NCT06024590 Recruiting - Diabetic Foot Ulcer Clinical Trials

Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers

Start date: October 3, 2023
Phase: Phase 4
Study type: Interventional

Irriseptâ„¢ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.

NCT ID: NCT06004219 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Peer Support for Patients With Diabetic Foot Ulcers

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.

NCT ID: NCT06003400 Recruiting - Diabetic Foot Ulcer Clinical Trials

Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

TriO FITT
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.

NCT ID: NCT05930210 Recruiting - Diabetes Mellitus Clinical Trials

A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer

Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (<16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing/observation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.

NCT ID: NCT05850611 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

Start date: April 30, 2023
Phase: Early Phase 1
Study type: Interventional

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

NCT ID: NCT05804097 Recruiting - Diabetic Foot Ulcer Clinical Trials

Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

DIONYSIUS
Start date: October 8, 2021
Phase: Phase 4
Study type: Interventional

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: - What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

NCT ID: NCT05772507 Recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection

NCT ID: NCT05758545 Recruiting - Diabetic Foot Ulcer Clinical Trials

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

Mavericks
Start date: June 19, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device at 12 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

NCT ID: NCT05613985 Recruiting - Clinical trials for Diabetic Foot Infection

PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers

PHOTOFINISH
Start date: September 14, 2021
Phase: N/A
Study type: Interventional

The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus / VULNOLIGHT® to the Usual Care, versus the treatment with Usual Care alone, for the healing of chronic diabetic foot ulcer. VULNOFAST® plus is a sterile solution used in combination with a red light source VULNOLIGHT®. Usual Care is defined as procedures to apply to the foot ulcer, carried out in the order in which they are listed in the protocol.

NCT ID: NCT05610865 Recruiting - Diabetes Mellitus Clinical Trials

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Start date: November 20, 2020
Phase: Phase 1
Study type: Interventional

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.