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Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

NCT01762085 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-06-26

No results posted yet for this study

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.

Conditions

  • Diabetic Ulcer of Plantar Aspect of Left Foot
  • Diabetic Ulcer of Plantar Aspect of Right Foot
  • Diabetic Polyneuropathy

Interventions

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.

Sponsors & Collaborators

  • Association of Extremity Nerve Surgeons

    lead OTHER

Principal Investigators

  • D. Scott Nickerson, MD · NE Wyoming Wound Care Center, consultant

  • Stephen L. Barrett, DPM · Barrett Foot & Ankle Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762085 on ClinicalTrials.gov