Infectious Disease Specialists of Atlanta, PC
Decatur, Georgia, 30033, United States
NCT Number: NCT03529578
The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Decatur, Georgia, 30033, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA)
Time frame: 8 Weeks
The percentage of subjects with complete wound closure of the study ulcer
Time frame: 8 weeks
Total time for complete wound healing
Time frame: 8 weeks
Percentage of wounds with total closure at each weekly visit time point
Time frame: 8 weeks
Rate of wound closure/week
Time frame: 8 weeks
The endpoints for safety will be reported as the frequencies of occurrence of each adverse event, the rate of adverse events per patient/month and time to each event; Both serious and non-serious adverse events will be recorded
Time frame: 8 weeks
Additionally, wound infection rates will be noted throughout the course of the study
Time frame: 8 weeks
Comparison of Quality of Life for subjects after treatment; This data will be measured by the SF-12 Health Survey at three time points throughout the study (8 weeks): prior to treatment, at 4 weeks, and at the end of the trial.
MiMedx Group, Inc.
Industry
A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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