ENRF's mission is to provide charitable outreach & promote scientific research & education for extremity nerve treatment.
The Foundation is supported by donations and payment plans are available. Be a part of the future!
from D. Scott Nickerson, MD, FAAOS - ENRF Research Chair
One application of nerve decompression surgery for which we have trained is to treat DSPN diabetes neuropathy complications like pain and diabetic foot ulcer complications, both indications which have been viewed skeptically by our professional colleagues, neurologists and endocrinologists. Strong science like prospective randomized control trials is necessary to convince others of the value and superior results which decompression can provide for pain and DFU prevention. For DSPN pain, we now have Dr. Shai Rozen’s study. For DFU complications we have the Western IRB approved DURA study (for Nerve Decompression for Ulcer Recurrence Avoidance). This is Clinicaltrials.gov Identifier: NCT01762085.
DURA is based on 5 retrospective studies which have shown decompressions produce > 85% reduction in toe amputation and DFU recurrence risk. This approach could soon save $1 billion in medical DFU costs annually and your patients would be most grateful.
But this is not merely an altruistic patient care and societal economic benefit. The billion dollar saving results from avoiding DFU recurrences using bilateral decompression of leg nerves in the setting of a healed neuropathic DFU. And can you guess who is performing, and being paid for, the surgical decompressions? That would be surgeons trained in and performing the Dellon decompression procedures, namely you! A single patient having bilateral procedures will generate more than $1000 in fees for you.
The Baylor, Scott and White podiatry faculty in Texas have now joined several AENS private DPM surgeons who are associated with DURA to carry out this Level 1 EBM study. A Research Contract has been signed and duplicate IRB approval by the Baylor Research IRB is imminent. The budget for DURA at BSW is at minimum $220,000. I have been able to raise from personal, professional and private foundation supporters around $175,000. Attendees at the recent AENS Annual Symposium gave or pledged $50,000 of this amount.
I invite you to join us in making a significant tax deductible personal or business expense gift commitment to raise the necessary $45,000 to accomplish this strong science DURA study. Your gift is an investment in your future surgical income as there are estimated to be 300,000 neuropathic DFU cases per year.
The Extremity Nerve Research Foundation (ENRF) is the 501c3 charitable arm of the Association of Extremity Nerve Surgeons. One of the research projects ENRF is supporting is the DURA study. Past analyses of patients who have painful diabetic neuropathy, or nerve damage, found that those who had the outpatient surgery procedure of nerve decompression (ND) not only found pain relief, but also seemed to have protection against the common and dangerous complication of diabetic foot ulcers (DFU). An exciting and unexpected finding was that the high, 30% per year, risk of recurrence after initial ulcer healing was reduced to under 5%.
The DFU problem has been extremely resistant to efforts at prevention of the initial wound and its expensive, dangerous and debilitating recurrences. The DFU patients are at high risk of a cascade of serious complications which include foot infection, the spread to systemic sepsis, gangrene, amputation of toes or foot or entire leg, and early mortality. Past research on the ND surgery results after healing a DFU has shown an 85% reduction in recurrences.
Yet the revolutionary and promising ND approach has encountered a good deal of skepticism and resistance from academics and medical professionals. This may be due to ND being based on the new understanding that nerve compressions commonly occur as a result of the metabolic disturbances of diabetes causing secondary nerve swelling. The swollen nerves can be pinched and trapped in tight anatomic locations and cause pain and numbness. Relief of this compression allows improved sensation which apparently protects against the foot ulcers. Proof of this ND effect should change the entire treatment paradigm and spare the diabetic patient from serious complications and great expense.
To provide convincing, irrefutable evidence that ND protects against DFU recurrences requires the strongest of scientific research protocols, designated to be a prospective randomized control trial. Such a study compares two similar patient groups who are randomly assigned to different treatments and whose later results are compared by statistics for significantly different outcome. For DURA participants who have recently healed a DFU, and the two treatments are 1) usual DFU aftercare and 2) usual aftercare plus ND of both legs. The outcome of interest is recurrence of a DFU.
People who have developed and healed a DFU on the sole of the foot may want to consider entering this research study at one of six DURA study sites to help prove whether ND is an effective protection from recurrence and its cascade of complications. Individuals, medical professionals, organizations or private foundations who have seen friends, patients, family or loved ones suffering from this dreadful and daunting diabetic complication may feel inspired to support this research. In either case you may ask for further information from firstname.lastname@example.org or the DURA study medical monitor who is D. Scott Nickerson, MD FAAOS at email@example.com or 307 752-9875.
The Guayquil, Ecuador mission is led by Dr. James Wilton. The mission is in conjunction with The Damien Foundation & The Luis Vernanza Hospital (the largest charity hospital in South America). This 1 week mission sees over 200 patients from area villages and treats diverse pathologies. Pathologies treated include: nerve damage from leprosy, reverse paralysis of arms and legs, and pediatric and adult extremity deformities. The team includes surgical assistants, hand orthopedists, podiatric physicians, anesthesiology staff, and local security. Contact AENS or Dr. Wilton for information regarding our 2019 trip!
RESEARCH: The ENRF research focus is to conduct and support scientific research to advance extremity nerve treatment. Without documentation, publications, scientific studies and communicating to patients, nerve treatment will NOT advance. Current protocols being discussed include intraepidermal nerve fiber density vs. PSSD, Nerve Decompression, and blood flow study, amputation impact, and Baxter's nerve. EMG NIM measurement of impact of nerve decompression has been submitted for publication.
The major study currently under way is the Nerve DURA study (Decompression for Ulcer Recurrence Avoidance). This is a multicenter, randomized, placebo controlled, non-blinded, clinical response trial evaluating changes in the incidence of recurring diabetic foot ulcers (DFU) after intervention for surgical nerve decompression (ND).The primary objective of the DURA study is measuring the incidence of recurring plantar foot ulcers amongst two study groups. The secondary objectives of the study include evaluating changes (from baseline) in Michigan Neuropathy Screening Index (MNSI), sensibility to vibration and touch, and pain by Visual Analog Pain Scale score (VAPS); quantifying the rate of infections and delayed healing for each study group and comparing risk of ulceration/re-ulceration on the contralateral limbs for patients who decline ND procedure.
To prospectively measure, after recent primary DFU wound healing, the incidence of recurring plantar foot ulcers, comparing DSPN cases receiving standard care as placebo to the intervention case of standard care plus surgical nerve decompression ND.
The Nerve DURA study is approved by an institutional review board, Western IRB, and listed as study NCT01762085 in ClinicalTrials.gov where the protocol and more details can be found.
2) OMNIFICENT STUDY - Contacts: Colorado State University & Dr. James Anderson, Ft. Collins, CO
Objective measured of nerve integrity, posture, gait and blood flow after nerve decompression in diabetic neuropathy patients. Patient Group: 30
3) GAIT STUDY - Contacts: Dr. James Anderson & Dr. Sonny Yamasaki.
For research projects, grants or donations, contact the main AENS office at firstname.lastname@example.org or Scott Nickerson, MD, ENRF research committee chair, at 307-674-9875. AENS support will be based on involvement of approved investigator, disclosure of indirect and direct costs, memorandum of understanding (MOU). IRB approvals, and time line commitment for publication of results.