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Diabetic Foot clinical trials

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NCT ID: NCT06292026 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy of ProgenaMatrix™ in the Management of DFUs

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™.

NCT ID: NCT06213337 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Virtual Classroom Training and SMS Supported Interventions Improving Foot Care and Self-Efficacy

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients. The basic questions the research aims to answer are: - Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? - Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent. In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.

NCT ID: NCT06003530 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200

Start date: January 6, 2022
Phase: Phase 1
Study type: Interventional

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).

NCT ID: NCT05873049 Active, not recruiting - Clinical trials for Infection, Surgical Site

Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The study evaluates the efficacy of fluorescence-guided de-colonization in patients with non-infected diabetic foot ulcers. The efficacy will also be compared between those who used artificial dermis and split-thickness skin graft for reconstruction surgery.

NCT ID: NCT05831059 Active, not recruiting - Diabetic Foot Clinical Trials

A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.

NCT ID: NCT05687643 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers

SLIPSTREAM
Start date: July 1, 2022
Phase:
Study type: Observational

Stain Analysis Mapping of the Plantar surface (STAMP) is a method designed by the University of Leeds to measure 'in-shoe' strain patterns on the plantar surface of the foot. Shear Load Inductive Plantar Sensing (SLIPS) is an insole designed by the University of Leeds to measure plantar shear stress and plantar pressure. This study aims to compare plantar strain using STAMP and plantar shear stress and plantar pressure using SLIPS in two groups of patients with diabetes; high risk patients with a recently healed plantar ulcer and low risk patients (according to the NICE definition).

NCT ID: NCT05174806 Active, not recruiting - Diabetic Foot Clinical Trials

Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients

Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

NCT ID: NCT05165628 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups: - Group 1: CYP-006TK - Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation. Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study. Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.

NCT ID: NCT05135130 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

Start date: October 4, 2021
Phase:
Study type: Observational

The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.

NCT ID: NCT05009602 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes

DM PAD
Start date: March 14, 2022
Phase:
Study type: Observational

In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard. The DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).