Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Association of Extremity Nerve Surgeons
Sponsor:
Information provided by (Responsible Party):
Association of Extremity Nerve Surgeons
ClinicalTrials.gov Identifier:
NCT01762085
First received: January 3, 2013
Last updated: July 30, 2013
Last verified: July 2013
  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:


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 appearance during the study.


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

  • Visual Analog Pain Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Patient report of pain level


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, or heat, with 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.

  • SPY Indocyanine green circulation evaluation [ Time Frame: pre-opo, post-op, study end ] [ Designated as safety issue: No ]
    This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation

  • Sudoscan evaluation of autonomic nerve control of sweating [ Time Frame: Pre-op, post-op, and study end ] [ Designated as safety issue: No ]
    This measure of autonomic nerve function will test whether nerve decompression produces any changes

  • Incidence of falls during the study [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Barrett Foot & Ankle Institute Recruiting
Phoenix, Arizona, United States, 85024
Contact: Steven L Barrett, DPM    480-478-0780    slbarrettpod@me.com   
Contact: John C Tassone, DPM    (602) 938-6960    jctassone@cox.net   
Principal Investigator: Stephen L Barrett, DPM         
Richard P. Jacoby Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Richard P Jacoby, DPM    480-994-5977    jacobydpm@gmail.com   
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    manish.bharara@gmail.com   
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    pvppc@psci.net   
Principal Investigator: Andrew P Rader, DPM         
United States, Texas
Damien Dauphinee Recruiting
Denton, Texas, United States, 76210
Contact: Damien Dauphinee, DPM    940-300-3054    dauphinee@completefootandanklecare.com   
Principal Investigator: Damien Dauphinee, DPM         
Maria Buitrago, DPM 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
Study Director: D. Scott Nickerson, MD NE Wyoming Wound Care Center, consultant
Principal Investigator: Stephen L. Barrett, DPM Barrett Foot & Ankle Institute
  More Information

Publications:

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: July 30, 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:
Diabetic Neuropathies
Polyneuropathies
Recurrence
Ulcer
Diabetes Complications
Diabetes Mellitus
Disease Attributes
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014