Diabetic Ulcer of Plantar Aspect of Left Foot, Diabetic Ulcer of Plantar Aspect of Right Foot, Diabetic Polyneuropathy
Conditions
Keywords
neuropathic diabetic foot ulcer, nerve decompression surgery
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.
Interventions
PROCEDUREnerve decompression
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
Sponsors
Association of Extremity Nerve Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of plantar foot ulceration wound | 2 years post-enrollment or post-op | Non- traumatic pressure wound or ulcer appearance during the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| measures of diabetic peripheral neuropathy (DPN) | 2 years | Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex |
| analgesic usage | 2 years | patients will log use of analgesic medications and changes in use. |
| any amputation | 24 months, 2 years | surgical removal of any part of the lower extremity, including toe |
| Incidence of falls during the study | 2 years | Prior history of falls will be defined and changes in risk of new falls in control and intervention groups. Balance has been reported to improve after nerve decompression. |
| SPY Indocyanine green circulation evaluation | pre-opo, post-op, study end | This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation |
| surgical wound infection | 3 months | swelling, redness, or heat, with pain after surgery |
| non-surgical foot infection | 24 months | foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg \>90 days post-op |
Countries
United States
Contacts
Primary ContactStephen Barrett, DPM
Backup ContactD. Scott Nickerson, MD
Outcome results
None listed