Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
NCT ID: NCT01762085
Last Updated: 2015-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2013-06-30
2016-12-31
Brief Summary
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Detailed Description
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If protection against ulcer occurrence were to be confirmed, a change in the treatment paradigm for diabetic neuropathy and foot ulcer could be appropriate.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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healed DFU control arm
clinic-specific usual "best care"
No interventions assigned to this group
healed DFU surgical intervention
clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment
nerve decompression
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
Interventions
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nerve decompression
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetic sensorimotor peripheral neuropathy
* Recently healed plantar neuropathic Diabetic Foot Ulcer (\< 18 months)
* At least one palpable foot or ankle pulse or ABI\>0.8 bilaterally.
* Recent Hgb A1c \< 9.0%
* Ankle edema absent or mild
Exclusion Criteria
* History of peripheral vascular arterial surgery
* History of peripheral nerve or lumbar disc surgery
* alcohol abuse(more than 2 drinks/day)
* untreated thyroid disorders
* B12 or Folate deficiency
* spondyloarthropathies
* hepatic disease
* advanced renal disease
* current lumbosacral radiculopathy or nerve compression
* toxin exposure including chemotherapeutic agents
18 Years
80 Years
ALL
No
Sponsors
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Association of Extremity Nerve Surgeons
OTHER
Responsible Party
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Principal Investigators
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D. Scott Nickerson, MD
Role: STUDY_DIRECTOR
NE Wyoming Wound Care Center, consultant
Stephen L. Barrett, DPM
Role: PRINCIPAL_INVESTIGATOR
Barrett Foot & Ankle Institute
Locations
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Barrett Foot & Ankle Institute
Phoenix, Arizona, United States
Richard P. Jacoby
Scottsdale, Arizona, United States
Southern Arizona Limb Salvage Alliance,
Tucson, Arizona, United States
Andrew Rader, DPM
Jasper, Indiana, United States
Damien Dauphinee
Denton, Texas, United States
Maria Buitrago, DPM
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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David Armstrong, DPM
Role: backup
References
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Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004 Dec;53(6):517-22. doi: 10.1097/01.sap.0000143605.60384.4e.
Dellon AL. Preventing foot ulceration and amputation by decompressing peripheral nerves in patients with diabetic neuropathy. Ostomy Wound Manage. 2002 Sep;48(9):36-45.
Dellon AL. Neurosurgical prevention of ulceration and amputation by decompression of lower extremity peripheral nerves in diabetic neuropathy: update 2006. Acta Neurochir Suppl. 2007;100:149-51. doi: 10.1007/978-3-211-72958-8_32.
Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5. doi: 10.7547/1000111.
Dellon AL, Muse VL, Nickerson DS, Akre T, Anderson SR, Barrett SL, Biddinger KR, Bregman PJ, Bullard BP, Dauphinee DM, DeJesus JM, DeJesus RA, Ducic I, Dunkerly J, Galina MR, Hung V, Ichtertz DR, Kutka MF, Jacoby RP, Johnson JB, Mader DW, Maloney CT Jr, Mancuso PJ, Martin RC, Martin RF, McDowel BA, Rizzo VJ, Rose M, Rosson GD, Shafiroff BB, Steck JK, Stolarski RG, Swier P, Wellens-Bruschayt TA, Wilke B, Williams EH, Wood MA, Wood WA, Younes MP, Yuksel F. Prevention of ulceration, amputation, and reduction of hospitalization: outcomes of a prospective multicenter trial of tibial neurolysis in patients with diabetic neuropathy. J Reconstr Microsurg. 2012 May;28(4):241-6. doi: 10.1055/s-0032-1306372. Epub 2012 Mar 12.
Dellon AL. A cause for optimism in diabetic neuropathy. Ann Plast Surg. 1988 Feb;20(2):103-5. doi: 10.1097/00000637-198802000-00001. No abstract available.
Dellon AL. Treatment of symptomatic diabetic neuropathy by surgical decompression of multiple peripheral nerves. Plast Reconstr Surg. 1992 Apr;89(4):689-97; discussion 698-9.
Rankin TM, Miller JD, Gruessner AC, Nickerson DS. Illustration of Cost Saving Implications of Lower Extremity Nerve Decompression to Prevent Recurrence of Diabetic Foot Ulceration. J Diabetes Sci Technol. 2015 Jul;9(4):873-80. doi: 10.1177/1932296815584796. Epub 2015 Jun 8.
Other Identifiers
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Nerve DURA
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WIRB 20122035
Identifier Type: -
Identifier Source: org_study_id
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