Trial record 21 of 303 for:    Pinched Nerve

Nerve Decompression for Ulcer Recurrence Avoidance (DURA) (DURA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01762085
Recruitment Status : Unknown
Verified June 2015 by Association of Extremity Nerve Surgeons.
Recruitment status was:  Recruiting
First Posted : January 7, 2013
Last Update Posted : June 26, 2015
Information provided by (Responsible Party):
Association of Extremity Nerve Surgeons

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Ulcer of Plantar Aspect of Left Foot Diabetic Ulcer of Plantar Aspect of Right Foot Diabetic Polyneuropathy Procedure: nerve decompression Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Study Start Date : June 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. occurrence of plantar foot ulceration wound [ Time Frame: 2 years post-enrollment or post-op ]
    Non- traumatic pressure wound or ulcer appearance during the study.

Secondary Outcome Measures :
  1. occurrence of delayed wound healing [ Time Frame: 3 months post nerve decompression ]
    failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain

  2. Visual Analog Pain Score [ Time Frame: 2 years ]
    Patient report of pain level

Other Outcome Measures:
  1. any amputation [ Time Frame: 24 months, 2 years ]
    surgical removal of any part of the lower extremity, including toe

  2. surgical wound infection [ Time Frame: 3 months ]
    swelling, redness, or heat, with pain after surgery

  3. non-surgical foot infection [ Time Frame: 24 months ]
    foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op

  4. measures of diabetic peripheral neuropathy (DPN) [ Time Frame: 2 years ]
    Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex

  5. analgesic usage [ Time Frame: 2 years ]
    patients will log use of analgesic medications and changes in use.

  6. SPY Indocyanine green circulation evaluation [ Time Frame: pre-opo, post-op, study end ]
    This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation

  7. Incidence of falls during the study [ Time Frame: 2 years ]
    Prior history of falls will be defined and changes in risk of new falls in control and intervention groups. Balance has been reported to improve after nerve decompression.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01762085

Contact: Stephen Barrett, DPM 623 572-3456
Contact: D. Scott Nickerson, MD 307 752-9875

United States, Arizona
Barrett Foot & Ankle Institute Recruiting
Phoenix, Arizona, United States, 85024
Contact: Steven L Barrett, DPM    480-478-0780   
Contact: John C Tassone, DPM    (602) 938-6960   
Principal Investigator: Stephen L Barrett, DPM         
Richard P. Jacoby Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Richard P Jacoby, DPM    480-994-5977   
Principal Investigator: Richard P Jacoby, DPM         
Southern Arizona Limb Salvage Alliance, Recruiting
Tucson, Arizona, United States, 85724-5072
Contact: Manish Bharara, PhD    520-626-1349   
Contact: David Armstrong, DPM    (520) 626-1349      
Principal Investigator: Manish Bharara, PhD         
United States, Indiana
Andrew Rader, DPM Recruiting
Jasper, Indiana, United States, 47546
Contact: Andrew P Rader, DPM    812-634-2778   
Principal Investigator: Andrew P Rader, DPM         
United States, Texas
Damien Dauphinee Recruiting
Denton, Texas, United States, 76210
Contact: Damien Dauphinee, DPM    940-300-3054   
Principal Investigator: Damien Dauphinee, DPM         
Maria Buitrago, DPM Recruiting
Houston, Texas, United States, 77092
Contact: Maria Buitrago, DPM    713-680-3668   
Principal Investigator: Maria Buitrago, DPM         
Sponsors and Collaborators
Association of Extremity Nerve Surgeons
Study Director: D. Scott Nickerson, MD NE Wyoming Wound Care Center, consultant
Principal Investigator: Stephen L. Barrett, DPM Barrett Foot & Ankle Institute


Responsible Party: Association of Extremity Nerve Surgeons Identifier: NCT01762085     History of Changes
Other Study ID Numbers: WIRB 20122035
Nerve DURA ( Other Grant/Funding Number: AENS/ENRF )
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Association of Extremity Nerve Surgeons:
neuropathic diabetic foot ulcer
nerve decompression surgery

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Neuropathies
Pathologic Processes
Disease Attributes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases