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Foot Ulcer clinical trials

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NCT ID: NCT04025853 Completed - Diabetic Foot Ulcer Clinical Trials

Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis

Start date: June 2015
Phase:
Study type: Observational

The investigators plan to do a retrospective chart review of 500 patients admitted to the hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. The investigators will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis. Levels of inflammatory biomarkers (CRP, ESR) will be collected from the charts from the first time of diagnosis. Because wound healing, biomarker levels and resolution of infection are clearly affected by other factors such as demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement and vascular surgery interventions these will also be collected. The investigators will collect this clinical data for both cohorts.

NCT ID: NCT03998436 Completed - Diabetic Foot Ulcer Clinical Trials

Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

Start date: December 26, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.

NCT ID: NCT03997526 Terminated - Diabetic Foot Ulcer Clinical Trials

3C Patch® Medicare Claims Study

Start date: July 15, 2020
Phase:
Study type: Observational

This prospective study will compare incidence rates of complete hard-to-heal diabetic foot ulcer healing in Medicare beneficiaries following application of the 3C Patch® plus usual care, tested against a historical control group of similar patients that received usual care during a randomized controlled trial.

NCT ID: NCT03993990 Withdrawn - Diabetic Foot Ulcer Clinical Trials

Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer

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

The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.

NCT ID: NCT03985306 Completed - Diabetic Foot Ulcer Clinical Trials

Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

This trial will examine the feasibility of conducting a definitive randomized clinical trial that tests whether inforatio technique will reduce time to healing of diabetic foot ulcers. Inforatio technique is a procedure where small punch biopsies are taken from the wound bed near the edge of the wound. With this technique, the investigators wish to initiate an acute inflammatory response that increases the generation of granulation tissue with subsequent healing by scar formation. Thus, the investigators hypothesize that inforatio technique will promote healing of diabetic foot ulcers. Based on clinical experience, the investigators have previously detected a reduction in time to healing as an unexpected effect when multiple punch biopsies are taken from the wound bed of diabetic foot ulcers. To the knowledge of the investigators, methods similar to the inforatio technique has not previously been studied.

NCT ID: NCT03978715 Completed - Diabetic Foot Ulcer Clinical Trials

The Effect of Implementing a Limb Loss Prevention Program on Amputation Rates

Start date: April 14, 2021
Phase:
Study type: Observational

The investigators plan to do a retrospective chart review on patients admitted to Parkland Hospital with diabetic foot infections, ulcers, and bone injuries from 2005 (5 years prior to the start of the diabetic limb preservation team) to present day. The investigators will collect information on demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement, wound healing, surgery interventions, complications, recurrence, and history and physical characteristics and exam from inpatient and outpatient encounters. This will be identified by current procedural terminology (CPT) codes for foot and leg amputations, and lower extremity revascularization procedures. Clinic visits will be identified to podiatry/foot wound, vascular surgery, invasive cardiology, general surgery, and physical therapy wound care in addition to inpatient encounters of these patients to determine the full scope of care received and to compare resources utilization before and after implementation of the diabetic limb preservation team.

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: NCT03958539 Not yet recruiting - Diabetes Mellitus Clinical Trials

Prevention Of Primary Foot Ulcers in High-risk Diabetes Patients

PROFOUND
Start date: August 5, 2019
Phase: N/A
Study type: Interventional

This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care

NCT ID: NCT03955289 Completed - Diabetic Foot Ulcer Clinical Trials

Treatment of Foot and Leg Ulcers Using a Laser

Start date: January 15, 2019
Phase:
Study type: Observational

The investigators plan to do a retrospective chart review on patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic.

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.