Diabetic Polyneuropathy Clinical Trial
Official title:
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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