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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT04828304 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

PLASOMA Ultimate Safety & Efficacy Study

PULSE
Start date: May 26, 2021
Phase: N/A
Study type: Interventional

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: 1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; 2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: - FU1: 2 weeks after end treatment period - FU2: 12 weeks after end treatment period - FU3: 12 months after start treatment.

NCT ID: NCT04210609 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

VHTDFU2
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

NCT ID: NCT04133493 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Omega3 Wound Fish Skin Graft in the Treatment of DFUs

Start date: July 31, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound

NCT ID: NCT03754465 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

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

Start date: May 9, 2019
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 Foot Ulcers, compared to placebo therapy.

NCT ID: NCT03166423 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy and Safety of Snail Slime and Natural Extracts for Healing in Diabetic Foot Ulcers

Start date: November 12, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and safety of the use of a formulation of snail slime and natural extracts, for the curative treatment of ulcer wonds in diabetic foot. The secondary objetives: 1. To evaluate the efficacy of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) for the curative treatment of ulcer wonds in diabetic foot with respect to the standard of care, by means the application of patchs that containing the formulation in a treatment period of until 60 days. 2. To determine the safety of the use of a formulation of snail slime Helix aspersa Müller and natural extracts (MU001) in diabetic individuals in a treatment period of until 60 days.

NCT ID: NCT03041844 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes

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

The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.

NCT ID: NCT03010215 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

DiabeticMIS1
Start date: January 2010
Phase: N/A
Study type: Interventional

Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this pathologic case. The purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic through MIS.

NCT ID: NCT02989961 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of Resticutis Compared to Platelet-Poor Plasma for Treating Diabetic Foot Ulcers

Start date: November 15, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of Resticutis for the treatment of Wagner's Grade II/III diabetic foot ulcers in comparison with Platelet-Poor Plasma as a placebo comparator.

NCT ID: NCT02326337 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

TWO2DFU
Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

NCT ID: NCT00926068 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers

Truheal
Start date: February 2010
Phase: Phase 2
Study type: Interventional

A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.