Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: nerve decompression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: healed DFU control arm<br>clinic-specific usual best care | |
| Experimental: healed DFU surgical intervention<br>clinic-specific best care plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment | Procedure: nerve decompression<br>* surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.<br>* Other names: surgical decompression;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of plantar foot ulceration wound | 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 | 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 | Patient report of pain level | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathic diabetic foot ulcer, nerve decompression surgery