Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
Data Collection
Collected from past medical records and data - RetrospectiveWounds and Injuries
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements: Necrotizing fasciitis Compromised/failed skin grafts/flaps Chronic refractory osteomyelitis Soft tissue radiation necrosis Diabetic wounds, lower extremity Acute peripheral arterial insufficiency Crush injury Venous leg disease Pressure ulcer Other chronic, non-healing wounds Subjects must have signed the Informed Consent Forms. Exclusion Criteria Female subjects who are pregnant or nursing. Anyone who is unable to give written informed consent Subjects with end-stage renal disease or who require peritoneal or hemodialysis. Subjects with current malignancies.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location