A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 12
- Primary Endpoint
- occurrence of plantar foot ulceration wound
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
occurrence of plantar foot ulceration wound
Time Frame: 2 years post-enrollment or post-op
Non- traumatic pressure wound or ulcer appearance during the study.
Secondary Outcomes
- occurrence of delayed wound healing(3 months post nerve decompression)
- Visual Analog Pain Score(2 years)