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New Diabetic Foot Ulcer Treatment Gets Approvals

04/23/2018

Origin, Inc (Princeton, NJ), a biotechnology company, announced that the US Food and Drug Administration approved the company’s request to conclude patient recruitment for the “GENESIS” Phase IIb trial of plasma-generated nitric oxide in patients with diabetic foot ulcers (DFUs). The conclusion follows positive interim analysis and evidence of healing in chronic DFUs in a sample of 83 randomized patients treated with topical application of plasma-generated nitric oxide. Data from the Phase IIb trial will allow the company to develop safety and effectiveness hypotheses needed to progress to Phase III trial design.

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Today's Wound Clinic Newsletter

Letter From the Editor

Guest Editorial
Advocate for Your Wound Care Patients on the Proposed MAC Policy on CTPs
05/29/2024
Eric J. Lullove, DPM, CWSP
The MACs recently released proposed coverage policy updates for applying CTPs for DFUs and VLUs. This is your opportunity to effect change by submitting comments to the MACs before the policy becomes final. You have a responsibility to know...
The MACs recently released proposed coverage policy updates for applying CTPs for DFUs and VLUs. This is your opportunity to effect change by submitting comments to the MACs before the policy becomes final. You have a responsibility to know...
The MACs recently released...
05/29/2024
Today's Wound Clinic
From the Editor
The Future of Wound Care in the Quality Payment Program
03/13/2024
Whether we will be able to survive as wound care practitioners will, at least in part, depend on having quality measures that are relevant to what we actually do.
Whether we will be able to survive as wound care practitioners will, at least in part, depend on having quality measures that are relevant to what we actually do.
Whether we will be able to...
03/13/2024
Today's Wound Clinic
From the Editor
The Non-Pressure Ulcer Episode-Based Cost Measure "Field Test" Began Feb. 1
02/05/2024
For years I have been explaining how the QPP could be the end of wound care practitioners. The entire QPP is designed around recognized medical specialties and since there is no recognized specialty for wound care, we are all in trouble.
For years I have been explaining how the QPP could be the end of wound care practitioners. The entire QPP is designed around recognized medical specialties and since there is no recognized specialty for wound care, we are all in trouble.
For years I have been explaining...
02/05/2024
Today's Wound Clinic
Guest Editorial
The G-Code Solution to Skin Substitute Reimbursement
01/25/2024
I am calling on CMS to adopt new G codes to replace Q code reimbursement and CPT 15000 codes for skin substitute application procedures and to establish skin substitute product code classes.
I am calling on CMS to adopt new G codes to replace Q code reimbursement and CPT 15000 codes for skin substitute application procedures and to establish skin substitute product code classes.
I am calling on CMS to adopt new...
01/25/2024
Today's Wound Clinic
Guest Editorial
Wound Size Matters: Analysis of the New Restrictive Skin Substitute LCD Policy
09/01/2023
With so much ambiguity remaining, an immediate compromise on the number of applications to allow 7 is warranted both from an ethical and medical perspective. The current restriction of 4 applications is clearly not based on an accurate...
With so much ambiguity remaining, an immediate compromise on the number of applications to allow 7 is warranted both from an ethical and medical perspective. The current restriction of 4 applications is clearly not based on an accurate...
With so much ambiguity...
09/01/2023
Today's Wound Clinic
Guest Editorial
Wrestling With Implicit Bias to Deliver Better Care for Our Patients
06/01/2023
For some, bias remains a sensitive issue, and some people are reluctant to admit to the need for introspection. However, to mitigate the ill effects of bias, everyone must first acknowledge that it exists.
For some, bias remains a sensitive issue, and some people are reluctant to admit to the need for introspection. However, to mitigate the ill effects of bias, everyone must first acknowledge that it exists.
For some, bias remains a...
06/01/2023
Today's Wound Clinic
From the Editor
Confessions of a Doctor With Lipedema
03/14/2023
It is hard to understand how demoralizing it is. Lipedema affects your entire life, starting in the teenage years.
It is hard to understand how demoralizing it is. Lipedema affects your entire life, starting in the teenage years.
It is hard to understand how...
03/14/2023
Today's Wound Clinic
From the Editor
Why Won’t the DME Provide Dressings for My Patient?
02/23/2023
Maybe Because Of My Documentation
Maybe Because Of My Documentation
Maybe Because Of My...
02/23/2023
Today's Wound Clinic
Guest Editorial
How Wound Care Providers Can Treat Patients Like People, Not Like Cases
02/01/2023
Finding a skilled wound care professional comes down finding someone who is confident in their skill/craft—someone who treats the whole patient, not just the wound. Finding someone who would see me as a person and a whole being rather than...
Finding a skilled wound care professional comes down finding someone who is confident in their skill/craft—someone who treats the whole patient, not just the wound. Finding someone who would see me as a person and a whole being rather than...
Finding a skilled wound care...
02/01/2023
Today's Wound Clinic
Guest Editorial
Amputations in Pyoderma Gangrenosum Patients: Underreported or Very Rare?
01/11/2023
Are providers missing the diagnosis of PG because they are anchoring on “positive” biopsy findings? Could we be missing cases in which PG patients underwent amputation, didn’t have a recurrence, and were never diagnosed? Or are we just not...
Are providers missing the diagnosis of PG because they are anchoring on “positive” biopsy findings? Could we be missing cases in which PG patients underwent amputation, didn’t have a recurrence, and were never diagnosed? Or are we just not...
Are providers missing the...
01/11/2023
Today's Wound Clinic

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Coping With COVID-19

Business Briefs
Telehealth Use Continues and Receives Further Medicare Payment 
01/25/2023
The COVID-19 PHE has been extended for 90 more days. This author reviews the Medicare telehealth flexibility extensions that may be important to wound/ulcer management professionals.
The COVID-19 PHE has been extended for 90 more days. This author reviews the Medicare telehealth flexibility extensions that may be important to wound/ulcer management professionals.
The COVID-19 PHE has been...
01/25/2023
Today's Wound Clinic
Business Briefs
The COVID-19 Public Health Emergency Waivers Q&A
09/07/2022
This author answers more questions about what will happen to telehealth and other waivers when the COVID-19 PHE ends.
This author answers more questions about what will happen to telehealth and other waivers when the COVID-19 PHE ends.
This author answers more...
09/07/2022
Today's Wound Clinic
Business Briefs
The COVID-19 Public Health Emergency Extension Also Applies to Telehealth
08/15/2022
The COVID-19 Public Health Emergency (PHE) is extended through October 13, 2022. Many wound/ulcer management professionals have been using telehealth and should be happy to know that the Medicare waivers pertaining to telehealth have also...
The COVID-19 Public Health Emergency (PHE) is extended through October 13, 2022. Many wound/ulcer management professionals have been using telehealth and should be happy to know that the Medicare waivers pertaining to telehealth have also...
The COVID-19 Public Health...
08/15/2022
Today's Wound Clinic
Business Briefs
The COVID-19 Public Health Emergency, Coding Changes, and Coverage Changes Continue
02/09/2022
For this month, let us review the continuation of the COVID-19 public health emergency (PHE), and the continuation of the ever-changing codes and coverage.
For this month, let us review the continuation of the COVID-19 public health emergency (PHE), and the continuation of the ever-changing codes and coverage.
For this month, let us review...
02/09/2022
Today's Wound Clinic

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