Evaluation of Fluorescence-image Guided Wound Assessment vs. Standard Practice
Foot UlcerDiabetic1 moreThe current trial aims to compare the assessment of diabetic foot ulcers by fluorescence image guidance to standard practice. The device will be used to acquire fluorescence images of diabetic foot ulcers: when wounds are illuminated by violet/blue light, most pathogenic bacterial species emit a unique red fluorescence signal. The device is intended to be used as part of the clinical assessment process, which may include visual assessment, signs of heat or high temperature, the presence of exudate, and redness in the area. Images will guide the clinician to inspect, sample or further evaluate areas where fluorescing bacteria is present. This study will allow us to determine the benefit of fluorescence image-guided procedure as compared to standard clinical practice to assess bacterial burden in diabetic foot ulcers. Microbiological swabbing under standard practice and fluoresce-guided imaging will be performed in order to compare the two techniques.
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic,...
Platelet-Derived Growth FactorDiabetic Foot1 moreThe purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials [neither the physician nor the patient knows the name of the study drug (PDGF-DBFT-003 and PDGF-DBFT-005].
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving...
Diabetic Foot UlcersThe study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
Diabetic Foot UlcerVenous Leg UlcerThis study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use. Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.
Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers
Diabetic Foot UlcerTemporomandibular Disorder1 moreThe aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are: Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving? What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers? Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.
Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis
Diabetic Foot UlcerThe 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.
A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the...
Charcot NeuroarthropathyDiabetic FootThe aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.
Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft...
Diabetic Foot UlcerDespite the widespread use of advanced biologics for the treatment of diabetic foot ulcers, data comparing one type of modality to another are scarce. This investigation is a prospective randomized study comparing a bioengineered skin substitute to a human skin allograft.
Efficacy and Safety of Heberprot-P® in Patients With Advanced Diabetic Foot Ulcer in Dasman Diabetes...
Diabetic FootThe purpose of this study is to assess the efficacy and safety of the intralesional administration of Heberprot-P® (human recombinant epidermal growth factor) plus the standard treatment in patients with complex diabetic foot and risk of major amputation in Kuwait.
Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm
Foot UlcerDiabeticThe main objective of this research study is to validate the St Joseph's Health Care Harmonized Foot Ulcer Assessment and Stratification tool using inter-rater reliability technique to determine if the score would consistently be reproducible by examiners of different role (Nurse Practitioner, Family physician, Registered Nurse and Resident). A validated assessment tool allows collecting better quality data with high comparability which enhances quality of foot care and increases the credibility of the tool.