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Diabetic Foot clinical trials

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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: NCT04323462 Recruiting - Diabetic Foot Ulcer Clinical Trials

Intensive Glycemic Control For Diabetic Foot Ulcer Healing

INGLOBE
Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates. A study showed improvement in phagocytic activity of macrophages after 5 days of intensive glycemic improvement in 21 patients of diabetes. Another retrospective cohort study studied the effect on HbA1c as predictor of healing rate in DFU. Latter found significant association of HbA1c with wound area healing rate. However a recent systematic review failed to find any randomized control trial comparing the effect of intensive versus conventional glycemic control for treating DFU. Hence, investigators want to explore the hypothesis by conducting a randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer in response to intensive glycemic control in comparison to conventional glycemic management.

NCT ID: NCT04315909 Recruiting - Clinical trials for Diabetic Foot Ulcers

The Effect of Platelet-Rich Plasma-Fibrin Glue in Combination With Vitamin E and C for Treatment of Non-healing Diabetic Foot Ulcers

Start date: August 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluates the chance of non-healing Diabetic Foot Ulcers repair by reducing oxidative stress caused by diabetes by taking vitamin E and C supplements along with the use of Platelet-Rich Plasma-Fibrin Glue as an effective treatment for wound healing.

NCT ID: NCT04310137 Recruiting - Diabetic Foot Ulcer Clinical Trials

Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.

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: NCT04289948 Withdrawn - Diabetes Clinical Trials

Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes

PDFI
Start date: March 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Work Package 1: Observational cohort pilot safety study Work Package 2: Randomised, double-blind, placebo controlled pilot study Work Package 3: Observer-blind pilot RCT

NCT ID: NCT04285710 Withdrawn - Diabetes Clinical Trials

Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

Start date: June 2021
Phase: N/A
Study type: Interventional

The key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if this treatment is capable of reducing the bacterial population number within infected wounds. The investigators' lab recently discovered that a specific survival protein called catalase can be destroyed through blue light exposure. Given that a majority of bacteria species contains catalase, it is hypothesized that the destruction of this protein can improve the effectiveness of antimicrobial wound dressings commonly used to treat infected diabetic wounds, therefore further reducing the amount of bacteria within the wound and increasing the rate of healing. By reducing the overall bacterial population within these diabetic infected wounds, the ability for these diabetic wounds to heal will be enhanced, allowing for greater reductions in wound size over the course of the treatment. In this study, 40 subjects will be enrolled and randomly assigning subjects to either a control group or a phototherapy receiving experimental group. While control subjects will receive standard weekly debridement treatment procedures for infected diabetic ulcers, experimental subjects will receive standard weekly debridement treatment alongside 2 sessions of phototherapy every week over the course of 12 weeks. Bacterial swab samples will be taken alongside the excised debrided infect tissue for the purpose of bacterial population analysis. For each patient, the changes in total bacterial population, wound size, and subject satisfaction will be recorded and analyzed to determine the effectiveness of pulsed light phototherapy.

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: NCT04280016 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Effect of Exercise on Wound Healing While Off-loading

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

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

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.