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Foot Ulcer clinical trials

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NCT ID: NCT04164641 Recruiting - Diabetic Foot Ulcer Clinical Trials

Noraxon myoRESEARCHâ„¢ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

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

Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot 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: 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: NCT04058639 Recruiting - Diabetic Foot Ulcer Clinical Trials

Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results. Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.

NCT ID: NCT03960255 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Start date: February 20, 2021
Phase:
Study type: Observational

Diabetic foot ulcers (DFUs) and their associated complications like amputations are increasingly becoming a problem in low and middle income (LMI) countries. Obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in LMI setting. It is however not certain whether increased adiposity, may make it difficult for DFUs to heal. Investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of DFUs.

NCT ID: NCT03942081 Recruiting - Clinical trials for Foot Ulcer, Diabetic

Diabetic Foot Ulcer Imaging- Study 2

Start date: September 5, 2017
Phase: N/A
Study type: Interventional

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

NCT ID: NCT03934944 Recruiting - Diabetic Foot Ulcer Clinical Trials

A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot

Start date: February 10, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to compare foot care knowledge, behaviour and glycaemic control in patients at increased risk of diabetic foot ulcers. Participants will receive either usual diabetic foot care education and follow-up as per evidence-based guidelines or usual care and follow-up, supplemented with an educational video and weekly foot alerts via a phone application.

NCT ID: NCT03855514 Recruiting - Diabetic Foot Ulcer Clinical Trials

Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

DFUs
Start date: February 8, 2019
Phase: N/A
Study type: Interventional

This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.

NCT ID: NCT03740581 Recruiting - Diabetic Foot Ulcer Clinical Trials

Intensive Versus Conventional Glycemic Control in Diabetic Foot Ulcer Healing

InVeCoG:DFU
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Diabetic foot ulcer is one of the most serious, most costly and at times life threatening complication of diabetes. The lifetime incidence of foot ulcer occurrence in diabetes is up to 25%. Despite the advent of numerous types of wound dressings and off-loading mechanisms, the ulcer healing rates in diabetes have remained dismally low. Hyperglycemia impairs the inflammatory, proliferative and remodeling phases of an ulcer. There are retrospective studies linking improvement of HbA1c to wound area healing rate. The investigators hypothesised that intensive glycemic control in a patient of diabetic foot ulcer improves the healing process. To explore this hypothesis, the investigators are conducting this randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer on either intensive glycemic treatment or conventional (pre-existing) glycemic treatment.