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Foot Ulcer clinical trials

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NCT ID: NCT04131608 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Start date: February 1, 2021
Phase:
Study type: Observational

Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

NCT ID: NCT04123093 Terminated - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of the Noxsano Wound Care Bandage

Start date: August 9, 2019
Phase: N/A
Study type: Interventional

This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity ulceration and/or arterial insufficiency lower extremity ulceration.

NCT ID: NCT04117269 Recruiting - Diabetic Foot Ulcer Clinical Trials

External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.

NCT ID: NCT04104451 Completed - Diabetic Foot Ulcer Clinical Trials

PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Start date: November 12, 2019
Phase: Phase 1
Study type: Interventional

Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).

NCT ID: NCT04098562 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

Start date: October 2019
Phase: Phase 2
Study type: Interventional

Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37. In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.

NCT ID: NCT04093635 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Start date: November 2019
Phase:
Study type: Observational

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers • The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.

NCT ID: NCT04090008 Completed - Diabetic Foot Clinical Trials

A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.

NCT ID: NCT04085926 Recruiting - Diabetic Foot Clinical Trials

Sealed Therapeutic Shoe as Treatment of Diabetic Foot Ulcers

Start date: August 2, 2019
Phase: N/A
Study type: Interventional

Total contact casts (TCCs) are effective treatment of plantar diabetic foot ulcers because they effectively offload the ulcer and are non-removable, resulting in high adherence to using the device. However, TCCs are not widely used in clinical practice because they negatively impact gait and daily activities. A new treatment concept was invented, sealed therapeutic shoe, where a shoe with a custom-made insole offloads the ulcer, and the shoe is rendered irremovable to be worn day and night, like a TCC. In this multicenter randomized controlled trial (RCT), 150 participants will be recruited and randomized to two treatment arms: TCC or sealed therapeutic shoe. The primary outcome is ulcer healing, secondary outcomes include (but are not limited to) skin complications, glycemic control, body mass index, gait function, balance, quality of life, physical activity, and health economics.

NCT ID: NCT04085705 Recruiting - Diabetic Foot Clinical Trials

The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)

PAID
Start date: September 17, 2019
Phase:
Study type: Observational

Rationale: Foot ulcers among diabetics are common. The presence of a contact allergy limits the healing process. Contact allergies for wound dressings are common among patients with ulcers caused by venous insufficiency but less is known about contact allergies in diabetic patients with ulcers. Objective: To determine the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers. Study design: A prospective multicenter study. Study population: Patients (n=139) with diabetic foot ulcers caused by type 1 or 2 diabetes mellitus treated at Rijnstate Hospital Arnhem, the Netherlands. Main study parameters/endpoints: The primary study parameter is the presence of contact allergies for wound dressings. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An allergy test is standard procedure at Rijnstate Hospital, there is no direct technique-related burden or risk for the patient. In addition, wound dressings can be adjusted in patients where a contact allergy is determined which will benefit the prognosis of these patients. The data of this study will give insight in the prevalence of contact allergies for wound dressings in patients with diabetic foot ulcers.

NCT ID: NCT04078854 Terminated - Sexual Dysfunction Clinical Trials

The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

Start date: July 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of two types of education on HbA1c level and future amputations in inpatient diabetics after initial minor foot amputation