Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

Status unconfirmed · Not applicable

Conditions studied: Diabetic Ulcer of Plantar Aspect of Left Foot, Diabetic Ulcer of Plantar Aspect of Right Foot, Diabetic Polyneuropathy

In brief

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.

Key facts

Study ID

NCT01762085

Run by

Association of Extremity Nerve Surgeons

People needed

120

Starts

2013-06-01

Expected to finish

2016-12-01

Last updated by the study team

2015-06-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrett Foot & Ankle Institute — Phoenix, Arizona, United States (enrolling)
• Richard P. Jacoby — Scottsdale, Arizona, United States (enrolling)
• Southern Arizona Limb Salvage Alliance, — Tucson, Arizona, United States (enrolling)
• Andrew Rader, DPM — Jasper, Indiana, United States (enrolling)
• Damien Dauphinee — Denton, Texas, United States (enrolling)
• Maria Buitrago, DPM — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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