Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

Association of Extremity Nerve Surgeons

Status: Unknown

Conditions: Diabetic Ulcer of Plantar Aspect of Right Foot; Diabetic Ulcer of Plantar Aspect of Left Foot; Diabetic Polyneuropathy

Treatments: Procedure: nerve decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT01762085

WIRB 20122035

Nerve DURA (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

healed DFU control arm

Placebo Comparator group

Description:

clinic-specific usual "best care"

healed DFU surgical intervention

Experimental group

Description:

clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment

Treatment:

Procedure: nerve decompression