Surgical Decompression for Diabetic Neuropathy in the Foot

Timothy J. Best Medicine Professional Corporation

Status

Completed

Conditions

Diabetic Polyneuropathy

Treatments

Procedure: Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01006915

DPNPSI-1

Details and patient eligibility

About

The purpose of the study is to determine whether or not surgical decompression of the common peroneal, tibial, and deep peroneal nerves in the legs of persons with diabetic peripheral neuropathy is effective treatment.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years
Presence of Type 1 or 2 diabetes mellitus (fasting plasma glucose > 7 mmol/L or casual plasma glucose > 11.1 mmol/L and symptoms of diabetes or a 2hr plasma glucose in a 75g oral glucose tolerance test > 11.1 mmol/L)
Symptoms of paresthesias (including burning pain) or numbness present symmetrically in both feet, determined to be on a peripheral nerve basis
Total Neuropathy score of ≥ 2 based on symptoms, signs, and nerve conduction study abnormality
Average pain on Likert scale (range 0 - 10) ≥5
Good diabetic control with Hgb A1C < 8
Presence of Tinel's sign at the Tarsal Tunnel
Possession of valid Ontario Hospital Insurance Plan (OHIP) coverage

Exclusion criteria

Other types of diabetes mellitus (gestational, drug-induced, etc.)
Other cause of neuropathy than diabetes such as vasculitis, amyloidosis, toxic neuropathy, HIV, renal failure, alcohol abuse, etc. Pure entrapment neuropathy without evidence of DSP
Symptomatic lumbosacral spine disease
Symptomatic lower extremity vascular disease
Previous foot ulceration or amputation. Other contraindications to surgery such as significant ankle edema, venous stasis, morbid obesity, or previous surgery/injury which would be incompatible with appropriate wound healing
History of Peripheral Arterial Disease
HbA1c > 8.0 - Adults lacking capacity to consent, pregnant women, prisoners, non-English speakers who require an interpreter, and those unwilling or unable to participate in the full study follow-up