Controlled Randomized Double Blinded Prospective Study on the Role of Decompression of Lower Extremity Nerves for the Treatment of Patients with Symptomatic Diabetic Neuropathy With Chronic Nerve Compression

Study ID
Study00000094

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern University Hospital– Zale Lipshy
  • Parkland Health & Hospital System

Contact
Annamaria Salvador
214-648-7284
annamaria.salvador@utsouthwestern.edu

Principal Investigator
Shai Rozen

Summary

The goal of this study is to examine whether decompression of peripheral nerves in the lower extremities alleviates pain, restores protective sensation, and improves the quality of life in patients suffering from diabetes with symptomatic peripheral neuropathy and superimposed chronic nerve compression.

in order to ensure that the effects of nerve decompression reported in previous studies can be generalized to the entire population at risk, and to provide Level i evidence as to the potential benefit of nerve decompression, a double blinded, prospective, randomized, controlled study is proposed. Despite the surgeon being the only researcher knowing which leg is operated, the study is blinded since neither the surgeon nor any of the other researchers in the study will be participating in the final evaluation of the patient. They will only evaluate the patients as part of the routine follow up and patient care. Final assessment will be performed by an independent, blinded, third party. This study protocol follows the strict guidelines proposed by the american academy of neurology regarding nerve decompression in patients with symptomatic diabetic neuropathy in order to consider the data level one evidence. For this purpose an interdisciplinary group has been assembled including specialists from the Department of internal Medicine x division of endocrinology, Department of neurology, Department of Physical Medicine and Rehabilitation, and Department of Plastic Surgery. The study protocol is detailed and lengthy but following are the essentials of the study. initial screening of the patients is performed at three clinics: neurology, physical medicine and rehabilitation, and endocrinology. Patients fitting this initial screening will return for a full screening visit including a comprehensive history and physical examination, foot hygiene assessment, glucose management, and administration of quality of life questionnaires. Final recruitment of individuals will be based on defined inclusion and exclusion criteria including failed medical treatment of at least one year, bilateral symptoms, and fully informed consent of the nature of the study. a second visit will include a comprehensive neurological evaluation in the neurology clinic including both history and physical examination and nerve testing. Patients will then be randomized into two groups: a non surgical group which will continue to receive a very comprehensive medical treatment regimen by all subspecialties and a surgical group which will further be randomized into left or right lower extremity nerve decompression. During surgery one leg will undergo nerve decompression and the other leg will receive similar incisions without decompression. This is done under the safest and most sterile conditions and followed up closely in the surgical clinic. The safety of the process has been reviewed in depth by several specialists. all patients will be evaluated at 3 month intervals. Twelve months after surgery results focusing on pain level, quality of life, and restoration of sensation will be assessed by third party evaluators unassociated to the study with no knowledge of the whether surgical intervention was used or its location. The results of this study will demonstrate whether there is a subgroup of patients with symptomatic diabetic neuropathy who may benefit from nerve decompression in order to significantly alleviate pain, improve quality of life and restore at least protective sensation. if the results are similar to those reported in the literature thus far, this will be the basis for a larger center and multicenter study with longer term evaluations including not only the aforementioned goals but more importantly the effect on ulceration formation, infection, and subsequent amputation in this high risk population.

Participant Eligibility

1) Type 1 or type 2 diabetes (non-insulin and insulin dependent)
2) Diagnoses of peripheral neuropathy based on criteria defined by the latest diabetic mellitus peripheral neuropathy studies.
3) Symptomatic neuropathy: Symptoms of either: a) Numbness b) Paresthesias c) Pain, or d) Numbness and pain, with or without a motor component.
4) Bilateral symptoms
5) Positive Tinel sign (tenderness upon percussion over the region of supposed nerve compression) on examination over the fibular neck, tarsal tunnel, or both.
6) Patients who have been treated non-surgically for at least a year prior to entering the study and continue to have symptoms.
7) Understanding of the study and the contents of the informed consent and agreement indicated by a signature
8) Time and ability to complete the study and comply with instructions
9) Ages 18-80
10) All genders
11) All races
12) Spanish speaking subjects will be eligible to participate. A translated consent and HIPAA will be provided, along with the use of a translator.