Nerve Decompression for Ulcer Recurrence Avoidance (DURA) - Full Text View

Purpose

Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve pinching and entrapment. Historical risk of 25% annually has been reported to decrease by >80% to under 5% yearly. Since an open wound precedes the large majority (85%) of amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the current academic opinion that nerve decompression will not decrease ulcer recurrence risk. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.

Condition	Intervention
Diabetic Ulcer of Plantar Aspect of Left Foot Diabetic Ulcer of Plantar Aspect of Right Foot Diabetic Polyneuropathy	Procedure: nerve decompression

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Further study details as provided by Association of Extremity Nerve Surgeons:

Primary Outcome Measures:

occurrence of plantar foot ulceration wound [ Time Frame: 2 years post-enrollment or post-op ] [ Designated as safety issue: No ]
Non- traumatic pressure wound or ulcer

Secondary Outcome Measures:

occurrence of delayed wound healing [ Time Frame: 3 months post nerve decompression ] [ Designated as safety issue: No ]
failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain

Other Outcome Measures:

any amputation [ Time Frame: 24 months, 2 years ] [ Designated as safety issue: No ]
surgical removal of any part of the lower extremity, including toe
surgical wound infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
swelling, redness, heat, or pain after surgery
non-surgical foot infection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op
measures of diabetic peripheral neuropathy (DPN) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex
analgesic usage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
patients will log use of analgesic medications and changes in use.

Estimated Enrollment:	120
Study Start Date:	February 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: healed DFU control arm clinic-specific usual "best care"
Experimental: healed DFU surgical intervention clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment	Procedure: 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 Names: nerve release external neurolysis surgical decompression

Detailed Description:

Diabetes patients with a recently healed, non-ischemic plantar diabetic foot ulcer will be randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot. Comparison of the control group with standard care to the surgical intervention group will be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be calculated. Additional subjective and objective secondary outcomes will be monitored. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.

If protection against ulcer occurrence were to be confirmed, a change in the treatment paradigm for diabetic neuropathy and foot ulcer could be appropriate.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 or Type 2 Diabetes Mellitus
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:

Ischemic peripheral vascular disease or ankle-brachial index (ABI)<0.8
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762085

Contacts

Contact: Stephen Barrett, DPM	623 572-3456	slbarrettpod@me.com
Contact: D. Scott Nickerson, MD	307 752-9875	thenix@fiberpipe.net

Locations

United States, Arizona
Thunderbird Internal Medicine	Not yet recruiting
Glendale, Arizona, United States, 85306
Contact: Steven L Barrett, DPM 602-938-6960 slbarrettpod@me.com
Contact: John C Tassone, DPM (602) 938-6960 jctassone@cox.net
Principal Investigator: Stephen L Barrett, DPM
Richard P. Jacoby	Not yet recruiting
Scottsdale, Arizona, United States, 85251
Contact: Richard P Jacoby, DPM 480-994-5977 acobydpm@gmail.com
Principal Investigator: Richard P Jacoby, DPM
Southern Arizona Limb Salvage Alliance,	Not yet recruiting
Tucson, Arizona, United States, 85724-5072
Contact: Manish Bharara, PhD 520-626-1349 manish.bharara@gmail.com
Contact: David Armstrong, DPM (520) 626-1349
Principal Investigator: Manish Bharara, PhD
United States, Indiana
Andrew Rader, DPM	Not yet recruiting
Jasper, Indiana, United States, 47546
Contact: Andrew P Rader, DPM 812-634-2778 pvppc@psci.net
Principal Investigator: Andrew P Rader, DPM
United States, Texas
Damien Dauphinee	Not yet recruiting
Denton, Texas, United States, 76210
Contact: Damien Dauphinee, DPM 940-300-3054 dauphinee@completefootandanklecare.com
Principal Investigator: Damien Dauphinee, DPM
Maria Buitrago, DPM	Not yet recruiting
Houston, Texas, United States, 77092
Contact: Maria Buitrago, DPM 713-680-3668 mobui@hotmail.com
Principal Investigator: Maria Buitrago, DPM

Sponsors and Collaborators

Association of Extremity Nerve Surgeons

Investigators

Principal Investigator:	Stephen L Barrett, DPM	Thunderbird Internal Medicine Group 5620 W. Thunderbird, Suite G-2 Glendale, AZ
Study Director:	D. Scott Nickerson, MD	NE Wyoming Wound Care Center, consultant

More Information

Publications:

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.

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. Review.

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.

Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5.

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.

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.

Responsible Party:	Association of Extremity Nerve Surgeons
ClinicalTrials.gov Identifier:	NCT01762085 History of Changes
Other Study ID Numbers:	WIRB 20122035, Nerve DURA
Study First Received:	January 3, 2013
Last Updated:	January 4, 2013
Health Authority:	United States: None

Keywords provided by Association of Extremity Nerve Surgeons:

neuropathic diabetic foot ulcer
nerve decompression surgery

Additional relevant MeSH terms:

Recurrence
Ulcer
Polyneuropathies
Diabetic Foot
Diabetic Neuropathies
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013