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| ID | Type | Description | Link |
|---|---|---|---|
| Nerve DURA | Other Grant/Funding Number | AENS/ENRF |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healed DFU control arm | Placebo Comparator | clinic-specific usual "best care" | |
| healed DFU surgical intervention | Experimental | clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nerve decompression | Procedure | surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| any amputation | surgical removal of any part of the lower extremity, including toe | 24 months, 2 years |
| surgical wound infection | swelling, redness, or heat, with pain after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Barrett, DPM | Contact | 623 572-3456 | slbarrettpod@me.com | |
| D. Scott Nickerson, MD | Contact | 307 752-9875 | thenix@fiberpipe.net |
| Name | Affiliation | Role |
|---|---|---|
| D. Scott Nickerson, MD | NE Wyoming Wound Care Center, consultant | Study Director |
| Stephen L. Barrett, DPM | Barrett Foot & Ankle Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrett Foot & Ankle Institute | Recruiting | Phoenix | Arizona | 85024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15602245 | Background | Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004 Dec;53(6):517-22. doi: 10.1097/01.sap.0000143605.60384.4e. | |
| 12271732 | Background | Dellon AL. Preventing foot ulceration and amputation by decompressing peripheral nerves in patients with diabetic neuropathy. Ostomy Wound Manage. 2002 Sep;48(9):36-45. |
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|
Patient report of pain level
| 2 years |
| 3 months |
| non-surgical foot infection | foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op | 24 months |
| measures of diabetic peripheral neuropathy (DPN) | Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex | 2 years |
| analgesic usage | patients will log use of analgesic medications and changes in use. | 2 years |
| SPY Indocyanine green circulation evaluation | This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation | pre-opo, post-op, study end |
| Incidence of falls during the study | 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. | 2 years |
| Richard P. Jacoby | Recruiting | Scottsdale | Arizona | 85251 | United States |
|
| Southern Arizona Limb Salvage Alliance, | Recruiting | Tucson | Arizona | 85724-5072 | United States |
|
| Andrew Rader, DPM | Recruiting | Jasper | Indiana | 47546 | United States |
|
| Damien Dauphinee | Recruiting | Denton | Texas | 76210 | United States |
|
| Maria Buitrago, DPM | Recruiting | Houston | Texas | 77092 | United States |
|
| 17985566 | Background | Dellon AL. Neurosurgical prevention of ulceration and amputation by decompression of lower extremity peripheral nerves in diabetic neuropathy: update 2006. Acta Neurochir Suppl. 2007;100:149-51. doi: 10.1007/978-3-211-72958-8_32. |
| 20237362 | Background | Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5. doi: 10.7547/1000111. |
| 22411624 | Background | Dellon AL, Muse VL, Nickerson DS, Akre T, Anderson SR, Barrett SL, Biddinger KR, Bregman PJ, Bullard BP, Dauphinee DM, DeJesus JM, DeJesus RA, Ducic I, Dunkerly J, Galina MR, Hung V, Ichtertz DR, Kutka MF, Jacoby RP, Johnson JB, Mader DW, Maloney CT Jr, Mancuso PJ, Martin RC, Martin RF, McDowel BA, Rizzo VJ, Rose M, Rosson GD, Shafiroff BB, Steck JK, Stolarski RG, Swier P, Wellens-Bruschayt TA, Wilke B, Williams EH, Wood MA, Wood WA, Younes MP, Yuksel F. Prevention of ulceration, amputation, and reduction of hospitalization: outcomes of a prospective multicenter trial of tibial neurolysis in patients with diabetic neuropathy. J Reconstr Microsurg. 2012 May;28(4):241-6. doi: 10.1055/s-0032-1306372. Epub 2012 Mar 12. |
| 3355053 | Background | Dellon AL. A cause for optimism in diabetic neuropathy. Ann Plast Surg. 1988 Feb;20(2):103-5. doi: 10.1097/00000637-198802000-00001. No abstract available. |
| 1546082 | Background | Dellon AL. Treatment of symptomatic diabetic neuropathy by surgical decompression of multiple peripheral nerves. Plast Reconstr Surg. 1992 Apr;89(4):689-97; discussion 698-9. |
| 26055081 | Background | Rankin TM, Miller JD, Gruessner AC, Nickerson DS. Illustration of Cost Saving Implications of Lower Extremity Nerve Decompression to Prevent Recurrence of Diabetic Foot Ulceration. J Diabetes Sci Technol. 2015 Jul;9(4):873-80. doi: 10.1177/1932296815584796. Epub 2015 Jun 8. |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019299 | Decompression, Surgical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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