Recruiting

Nerve Decompression

Sponsor:

Association of Extremity Nerve Surgeons

Code:

NCT01762085

Conditions

Diabetic Ulcer of Plantar Aspect of Left Foot

Diabetic Ulcer of Plantar Aspect of Right Foot

Diabetic Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

nerve decompression

Study Details

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.

Conditions

Diabetic Ulcer of Plantar Aspect of Left Foot

Diabetic Ulcer of Plantar Aspect of Right Foot

Diabetic Polyneuropathy

Study ID

NCT01762085

Start date

Jun, 2013

Status verified date

Jun, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • occurrence of plantar foot ulceration wound [ Time Frame: 2 years post-enrollment or post-op ]

Central Contacts and Locations

Central contacts

Stephen Barrett, DPM

623 572-3456slbarrettpod@me.com

D. Scott Nickerson, MD

307 752-9875thenix@fiberpipe.net

Locations

Barrett Foot & Ankle Institute

Recruiting

Phoenix, Arizona, United States, 85024

Contacts

Steven L Barrett, DPM

480-478-0780slbarrettpod@me.com

John C Tassone, DPM

(602) 938-6960jctassone@cox.net

Principal Investigator:

Stephen L Barrett, DPM

Richard P. Jacoby

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Richard P Jacoby, DPM

480-994-5977jacobydpm@gmail.com

Principal Investigator:

Richard P Jacoby, DPM

Southern Arizona Limb Salvage Alliance,

Recruiting

Tucson, Arizona, United States, 85724-5072

Contacts

Manish Bharara, PhD

520-626-1349manish.bharara@gmail.com

David Armstrong, DPM

(520) 626-1349

Principal Investigator:

Manish Bharara, PhD

Andrew Rader, DPM

Recruiting

Jasper, Indiana, United States, 47546

Contacts

Andrew P Rader, DPM

812-634-2778pvppc@psci.net

Principal Investigator:

Andrew P Rader, DPM

Damien Dauphinee

Recruiting

Denton, Texas, United States, 76210

Contacts

Damien Dauphinee, DPM

940-300-3054dauphinee@completefootandanklecare.com

Principal Investigator:

Damien Dauphinee, DPM

Maria Buitrago, DPM

Recruiting

Houston, Texas, United States, 77092

Contacts

Maria Buitrago, DPM

713-680-3668mobui@hotmail.com

Principal Investigator:

Maria Buitrago, DPM

More Information

Sponsor

Association of Extremity Nerve Surgeons

Last update posted

Jun 26, 2015

Last verified

Jun, 2015

Keywords

  • neuropathic diabetic foot ulcer
  • nerve decompression surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Association of Extremity Nerve Surgeons on 2015-06-26.