FDGL Dose-Finding Study for Diabetic Neuropathy

This is a single-center, double-blinded, parallel, randomized clinical trial conducted at Al-Hussein University Hospital, Cairo, Egypt. Eligible patients are randomized to receive either placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily FDGL doses in a 1:1:1:1:1 ratio using block randomization with a block size of 5. The study employs computer-assisted random number generation for treatment allocation. Both patients and nurses are blinded to treatment allocation, with assignments kept in sealed envelopes opened only at enrollment. The study duration is 3 months with follow-up assessments at 1, 2, and 3 months.

Inclusion criteria

• Adult patients aged between 18 and 70 years
• Documented history of type I or type II diabetes mellitus
• Confirmed diagnosis of at least one diabetes-related complication, including peripheral neuropathy
• Diagnosis of peripheral neuropathy confirmed in both lower extremities
• Numeric rating scores (VAS) on 0 to 10 scale ≥ 4 for at least 6 months in feet/legs
• Ability to provide written informed consent
• If using concurrent therapies for diabetic neuropathy (pregabalin, gabapentin, or duloxetine), must be on stable doses for at least 3 months prior to study start

Exclusion criteria

• Concomitant chronic kidney disease
• Hepatic impairment
• Heart failure
• Cancer
• Major psychiatric disorders
• Pregnancy
• Refusal to sign informed consent
• Use of non-pharmacologic management strategies for diabetic neuropathy including:

• TENS (Transcutaneous Electrical Nerve Stimulation)
• Nerve block procedures
• Acupuncture
• Laser therapy