A Prospective Randomized Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
ClinicalTrials.gov Identifier: NCT01762085
Summary
- You are being asked to be in a research study.
- Your decision to be in this study is voluntary.
- If you decide to be in this study and then change your mind, you can leave the study at any time.
- You are a desirable study participant because you have diabetes, nerve damage (neuropathy), adequate circulation and have healed a previous foot ulcer.
- The study will compare your risk of having a foot ulcer recur using either the best current treatments and foot care, or best treatments plus an outpatient operation for release of foot and leg nerves.
- The care (treatment) you receive in this study is standard medical care and will not change or replace your usual medical care from your doctor.
- The surgical procedure in this study is not experimental. The known risks of the surgery include delayed healing of the operation wound (5%). Any surgical wound can become infected (2% or less). Also, a nerve could be accidentally damaged during the course of the procedure.
- You will be in this study for about 2 years and have about 8 study visits.
- If you agree to be in this research study, your medical records will become part of this research. They may be looked at or copied by the sponsor of this study or government agencies or other groups associated with the study.
- Your medical insurance may be billed for any treatment you need, or for standard medical care that you receive as a part of this study. Your insurer would then have access to the research records and would know that you were in this study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time using ClinicalTrials.gov identifier #NCT01762085.
Study Description
Scientific literature suggests 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 with nerve decompression. 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 regarding nerve decompression and foot ulcer recurrence risk.
Condition or disease: Diabetic Polyneuropathy and Diabetic foot ulcer
Intervention/treatment: Nerve Decompression or Standard Post- Ulcer Care
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, pain level and ulcer recurrence risks will be calculated. Additional subjective and objective secondary outcomes will be monitored.
If protection against ulcer occurrence were to be confirmed, a change in the treatment
Study Design
| Arm | Intervention/Treatment |
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. Other Names: •nerve release •external neurolysis •surgical decompression |
Ages Eligible for Study
Male and Females 18 years to 80 Years
Criteria
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
- Recent Hgb A1c < 9.0%
- Mild or absent ankle swelling
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For more information visit the Dura research website, https://duraresearch.com, and the clinical trials website, https://www.clinicaltrials.gov/ct2/results?cond=&term=01762085&cntry=&state=&city=&dist=. Also, check out our diabetic facts and figures.
US Neuropathy Centers
Dr. Porscha Bailey
Dr. Sequioa DuCasse
Dr. Stephen Barrett
2550 Windy Hill Rd Suite 206
Marietta GA, 30067
Tel: 404 228 9892
Fax: 404 883 3969
usneuropathyatl@gmail.com
