The Association of Extremity Nerve Surgeons Proudly Announces the Formation of The Extremity Nerve Research Foundation (ENRF)The Foundation mission is to provide charitable outreach and promote scientific research and education for extremity nerve treatment.
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 info@AENS.us or the DURA study medical monitor
who is D. Scott Nickerson, MD FAAOS at firstname.lastname@example.org or 307 752-9875.
Dear AENS Member,
One of the missions of the AENS organization is furthering the dissemination of current knowledge and development of basic medical research in peripheral nerve disease. The Association’s vehicle for this is the ENRF, the Extremity Nerve Research Foundation. The ENRF now has an opportunity before us to do a research project which promises to do just that, to likely change the treatment paradigm of a serious and widespread problem in which foot specialists are the primary professionals involved.
You probably know that plastic surgeon Shai Rozen of U TX Southwestern has completed his DNND - Diabetic Neuropathy and Nerve Decompression study and presented it to the ADA Scientific Sessions last June to great interest. This proves beyond doubt that for painful DSPN, surgical nerve decompression (ND) is strongly effective with durable, long-lasting benefit for pain relief. DNND is being submitted to a major medical science journal for publication and one might anticipate a change in the paradigm of DSPN pain treatment should follow. AENS-trained fellows are likely to become economic beneficiaries of new appreciation of this now proven therapeutic tool for diabetic leg pain.
The opportunity for ENRF is to extend this hopeful finding to using ND for prevention of DFU development and protection from recurrence. ENRF is the sponsor of the IRB – approved EBM Level 1 DURA study examining the protective power of Decompression for Ulcer Recurrence Avoidance (Clincaltrials.gov study # NCT01762085) to prevent or minimize DFU recurrence risk. Those of you practicing in this field know of the 30% annual neuropathic DFU recurrence risk. Six lower EBM level retrospective studies by AENS scientists have shown risk reduced to < 5%/yr. Level 1 proof of such an 85% risk reduction would be another paradigm shifting result for ND in the neuropathic DFU situation.
So I am personally asking you to contribute $1000 or more to the effort to complete the DURA study. We now have an academic partner, the Baylor Scott and White podiatry division, able to provide and manage the research infrastructure of a major, 3 year clinical project like DURA. ENRF is taking responsibility for covering a significant portion of the DURA expense, estimated at $150,000 or more. Your gift can be made as a business expense or a personal charitable deduction. In either case this deductibility means that the IRS is actually providing 39.5% of the dollars should you be in a top tax bracket.
This is a rather unusual charitable appeal situation, with the likelihood of a multiplied return on your philanthropy. I think you can see you are likely to recover your donation many times over in surgical fees coming to you if bilateral ND is proven effective, as we hope, for protection from DFU recurrence. This will be true whether you now do wound care or not. Diabetics healed of their neuropathic DFU will be either told at the Wound Center or by word of mouth that ND is the way to avoid having further DFU expense, aggravation, medical risk, amputation or early mortality from the diabetic foot complication cascade.
Please give this ENRF appeal your careful economic, professional, altruistic and charitable consideration.
Scott Nickerson, MD
ENRF Research Chair
Please Note: ENRF is a 501c3 and donations ARE tax deductible.
Consider a year end donation for this effort!
Medical Mission Outreach: 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.
1) DURA STUDY - Contacts: Dr. Scott Nickerson
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 email@example.com 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.