Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
- Conditions
- Diabetic Ulcer of Plantar Aspect of Left FootDiabetic Ulcer of Plantar Aspect of Right FootDiabetic Polyneuropathy
- Interventions
- Procedure: nerve decompression
- Registration Number
- NCT01762085
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description healed DFU surgical intervention nerve decompression clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment
- Primary Outcome Measures
Name Time Method occurrence of plantar foot ulceration wound 2 years post-enrollment or post-op Non- traumatic pressure wound or ulcer appearance during the study.
- Secondary Outcome Measures
Name Time Method occurrence of delayed wound healing 3 months post nerve decompression failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
Visual Analog Pain Score 2 years Patient report of pain level
Trial Locations
- Locations (6)
Damien Dauphinee
🇺🇸Denton, Texas, United States
Richard P. Jacoby
🇺🇸Scottsdale, Arizona, United States
Southern Arizona Limb Salvage Alliance,
🇺🇸Tucson, Arizona, United States
Barrett Foot & Ankle Institute
🇺🇸Phoenix, Arizona, United States
Andrew Rader, DPM
🇺🇸Jasper, Indiana, United States
Maria Buitrago, DPM
🇺🇸Houston, Texas, United States