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

June 25, 2015 updated by: Association of Extremity Nerve Surgeons

A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression

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.

Study Overview

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

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85024
        • Recruiting
        • Barrett Foot & Ankle Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen L Barrett, DPM
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Richard P. Jacoby
        • Contact:
        • Principal Investigator:
          • Richard P Jacoby, DPM
      • Tucson, Arizona, United States, 85724-5072
        • Recruiting
        • Southern Arizona Limb Salvage Alliance,
        • Contact:
        • Contact:
          • David Armstrong, DPM
          • Phone Number: (520) 626-1349
        • Principal Investigator:
          • Manish Bharara, PhD
    • Indiana
      • Jasper, Indiana, United States, 47546
        • Recruiting
        • Andrew Rader, DPM
        • Contact:
          • Andrew P Rader, DPM
          • Phone Number: 812-634-2778
          • Email: pvppc@psci.net
        • Principal Investigator:
          • Andrew P Rader, DPM
    • Texas
      • Denton, Texas, United States, 76210
      • Houston, Texas, United States, 77092
        • Recruiting
        • Maria Buitrago, DPM
        • Contact:
        • Principal Investigator:
          • Maria Buitrago, DPM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years post-enrollment or post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months post nerve decompression
Visual Analog Pain Score
Time Frame: 2 years
Patient report of pain level
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
any amputation
Time Frame: 24 months, 2 years
surgical removal of any part of the lower extremity, including toe
24 months, 2 years
surgical wound infection
Time Frame: 3 months
swelling, redness, or heat, with pain after surgery
3 months
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
24 months
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
2 years
analgesic usage
Time Frame: 2 years
patients will log use of analgesic medications and changes in use.
2 years
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
pre-opo, post-op, study end
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: D. Scott Nickerson, MD, NE Wyoming Wound Care Center, consultant
  • Principal Investigator: Stephen L. Barrett, DPM, Barrett Foot & Ankle Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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