Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
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.
Diabetic Ulcer of Plantar Aspect of Left Foot
Diabetic Ulcer of Plantar Aspect of Right Foot
Procedure: nerve decompression
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression|
- occurrence of plantar foot ulceration wound [ Time Frame: 2 years post-enrollment or post-op ] [ Designated as safety issue: No ]Non- traumatic pressure wound or ulcer appearance during the study.
- occurrence of delayed wound healing [ Time Frame: 3 months post nerve decompression ] [ Designated as safety issue: No ]failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
- Visual Analog Pain Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]Patient report of pain level
- any amputation [ Time Frame: 24 months, 2 years ] [ Designated as safety issue: No ]surgical removal of any part of the lower extremity, including toe
- surgical wound infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]swelling, redness, or heat, with pain after surgery
- non-surgical foot infection [ Time Frame: 24 months ] [ Designated as safety issue: No ]foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op
- measures of diabetic peripheral neuropathy (DPN) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex
- analgesic usage [ Time Frame: 2 years ] [ Designated as safety issue: No ]patients will log use of analgesic medications and changes in use.
- SPY Indocyanine green circulation evaluation [ Time Frame: pre-opo, post-op, study end ] [ Designated as safety issue: No ]This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation
- Sudoscan evaluation of autonomic nerve control of sweating [ Time Frame: Pre-op, post-op, and study end ] [ Designated as safety issue: No ]This measure of autonomic nerve function will test whether nerve decompression produces any changes
- Incidence of falls during the study [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: healed DFU control arm
clinic-specific usual "best care"
Experimental: healed DFU surgical intervention
clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment
Procedure: nerve 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762085
|Contact: Stephen Barrett, DPM||623 firstname.lastname@example.org|
|Contact: D. Scott Nickerson, MD||307 email@example.com|
|United States, Arizona|
|Barrett Foot & Ankle Institute||Recruiting|
|Phoenix, Arizona, United States, 85024|
|Contact: Steven L Barrett, DPM 480-478-0780 firstname.lastname@example.org|
|Contact: John C Tassone, DPM (602) 938-6960 email@example.com|
|Principal Investigator: Stephen L Barrett, DPM|
|Richard P. Jacoby||Recruiting|
|Scottsdale, Arizona, United States, 85251|
|Contact: Richard P Jacoby, DPM 480-994-5977 firstname.lastname@example.org|
|Principal Investigator: Richard P Jacoby, DPM|
|Southern Arizona Limb Salvage Alliance,||Recruiting|
|Tucson, Arizona, United States, 85724-5072|
|Contact: Manish Bharara, PhD 520-626-1349 email@example.com|
|Contact: David Armstrong, DPM (520) 626-1349|
|Principal Investigator: Manish Bharara, PhD|
|United States, Indiana|
|Andrew Rader, DPM||Recruiting|
|Jasper, Indiana, United States, 47546|
|Contact: Andrew P Rader, DPM 812-634-2778 firstname.lastname@example.org|
|Principal Investigator: Andrew P Rader, DPM|
|United States, Texas|
|Denton, Texas, United States, 76210|
|Contact: Damien Dauphinee, DPM 940-300-3054 email@example.com|
|Principal Investigator: Damien Dauphinee, DPM|
|Maria Buitrago, DPM||Recruiting|
|Houston, Texas, United States, 77092|
|Contact: Maria Buitrago, DPM 713-680-3668 firstname.lastname@example.org|
|Principal Investigator: Maria Buitrago, DPM|
|Study Director:||D. Scott Nickerson, MD||NE Wyoming Wound Care Center, consultant|
|Principal Investigator:||Stephen L. Barrett, DPM||Barrett Foot & Ankle Institute|