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Diabetic Foot clinical trials

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NCT ID: NCT04337723 Completed - Diabetes Mellitus Clinical Trials

Implementation of ABI and WIfI in Rural Health Clinics

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for new patients with lower extremity ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at RHCs in the telemedicine network through a rural provider education program that is aligned with preexisting continuing medical education activities.

NCT ID: NCT04336176 Completed - Diabetic Foot Ulcer Clinical Trials

Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

Start date: March 22, 2018
Phase: N/A
Study type: Interventional

The impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. The new PulseFlow DF boot is a device which claims to off load but has little or no evidence on diabetic foot ulcer (DFU) subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.

NCT ID: NCT04327622 Completed - Clinical trials for Diabetes Mellitus, Type 2

Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population

PEDAL
Start date: March 3, 2020
Phase:
Study type: Observational

The study aims to assess foot complications among patients with diabetes in Canada, using patient data collected during diabetes foot assessments performed by the LMC Chiropody Team between February 27, 2018 and April 17, 2019.

NCT ID: NCT04300205 Completed - Diabetic Foot Ulcer Clinical Trials

High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers

Start date: February 25, 2020
Phase: N/A
Study type: Interventional

Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was $547 million. Standard clinical care for these types of wounds has improved but there is still a great need for new wound care treatments to help speed up wound healing and reduce pain. One such treatment is high intensity LED light therapy. There is a long history of light therapy showing faster wound healing, reduced pain and reduced swelling. The research we propose here is to study a new high intensity LED light made by Kerber Applied Research Inc., to see if it reduces pain and speeds up healing lower leg ulcers. This research is a partnership between Kerber Applied Research Inc and the Lethbridge Lower Limb Wound Clinic, an Alberta Health Services program in Lethbridge, Alberta.

NCT ID: NCT04281992 Completed - Diabetic Foot Ulcer Clinical Trials

Treatment of Diabetic Foot Ulcers With AUP1602-C

Start date: January 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a two-part phase 1/2A study performed in diabetic foot ulcer (DFU) patients with chronic non-healing wounds to investigate the safety and efficacy of AUP1602-C.

NCT ID: NCT04277598 Completed - Clinical trials for Diabetic Foot Ulcer (DFU)

A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer

Start date: October 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The MARSYAS II study which will be conducted in patients with diabetic foot ulcer (DFU) consists of a Lead-In Phase for safety assessment of multiple doses of the biologic investigational medicinal product (IMP) APO-2 and of a Main Phase (Phase II Study) to assess the efficacy and safety of the IMP. The phase II study will be a randomized study at multiple clinical centers and it will be double-blind meaning that neither the investigator nor the treated patient know if the IMP or a placebo is applied; the study will investigate the safety and clinical efficacy of multiple dose administrations at three dose levels of APO-2 (low dose, medium dose or high dose) compared with placebo.

NCT ID: NCT04265469 Completed - Clinical trials for Diabetic Foot, Mobile Application, Patient Education

Mobile Application For Educating Diabetics About Foot Care

Start date: February 10, 2016
Phase: N/A
Study type: Interventional

Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.

NCT ID: NCT04257370 Completed - Diabetic Foot Ulcer Clinical Trials

Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations

Odinn
Start date: July 9, 2020
Phase: N/A
Study type: Interventional

This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

NCT ID: NCT04255004 Completed - Diabetic Foot Clinical Trials

Autologous Peripheral Blood Mononuclear Cells in Diabetic Foot Patients With No-option Critical Limb Ischemia

Start date: January 2014
Phase: N/A
Study type: Interventional

The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.

NCT ID: NCT04246814 Completed - Diabetic Foot Ulcer Clinical Trials

Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Start date: August 27, 2019
Phase: N/A
Study type: Interventional

Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.