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Study Title and Description

Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.



Key Questions Addressed
1 KQ 1. What are the benefits and harms of treatment strategies including PRP alone with or without other wound care treatments compared with other wound care treatments in patients with diabetic, venous and pressure chronic wounds, for patient oriented outcomes such as at least the following: completely closed/healed wounds (skin closure with complete re-epithelialization without drainage or dressing requirements), time to complete wound closure, wound reoccurrence, risk of developing wound infection, amputation, hospitalization (frequency and duration), return to baseline activities and function, reduction of wound size, pain, opioid medication use, exudate and odor, quality of life and adverse effects? KQ 1.a. Describe the risk of bias in the studies examined by chronic wound type and study design. KQ 1.b What are the differences in formulation techniques and components between these preparations? What are the differences in application techniques, frequency of application and “dosage” (amounts applied)? KQ 1.c What are the study characteristics (such as those listed below) in each included investigation for each chronic wound type treated by PRP? i. Comparator (if standard care, describe in detail). ii. Study inclusion/exclusion criteria and patient characteristics of enrollees, including at least age, gender, and general health (e.g., status of HbA1c, diabetes, peripheral vascular disease, obesity, smoking, renal), wound characteristics, and prior and concurrent wound treatments. iii. Wound characteristics of enrollees including at least wound type, wound size/depth/duration/severity, vascular status, infection status and whether there were inter- and intra-rater checks of wound measurements. iv. Basic study design and conduct information including at least method of patient enrollment, care setting, and use of run-in period. v. Definition of wound characteristics: definition of “failure to heal”, and definition of a successfully healed wound (re-epithelialization). vi. Method of applying skin PRP including provider, frequency of application, definition of standard of care, and handling of infections. vii. Measurement and assessment methods including method of assessment(s); frequency and time points for assessment(s) (including long term assessments for durability of heal); and blinding of assessors. KQ 1.d Based on the included studies, what are the patient characteristics commonly considered for the initiation and continuation/discontinuation of PRP in patients with chronic wounds?
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Primary Publication Information
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TitleData
Title Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial.
Author Gude W., Hagan D., Abood F., Clausen P.
Country Warren Gude, MD, is Medical Director, St Luke's Wound and Hyperbaric Clinic; Medical Director, Wound Care at Vibra Hospital; and Medical Director of Wound Care, Meadow View Nursing and Rehabilitation Center, Boise, Idaho. Daniel Hagan, DPM, DABPS, is a podiatrist, Onslow Memorial Hospital Wound Care; and in private practice, Family Foot Care, Jacksonville, North Carolina. Ferial Abood, MD, is Medical Director of Internal Medicine, Advanced Wound Care of South Central New Mexico, Gerald Champion Hospital, Alamogordo, New Mexico. Peter Clausen, PhD, is Chief Science Officer, Nuo Therapeutics Inc, Gaithersburg, Maryland. Acknowledgments: Nuo Therapeutics (Gaithersburg, Maryland) sponsored this study and provided oversight and funding for third-party vendors that supported study operations, data storage, and statistical planning and analysis. Therapies were reimbursed by the Centers for Medicare & Medicaid Services in accordance with Medicare rules.
Year 2019
Numbers Pubmed ID: 31436621

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Platelet-Rich Plasma for Wound Care
Design Details
Question... Follow Up Answer Follow-up Answer




Results & Comparisons

No Results found.