Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01628627
Eligibility Criteria:
Inclusion Criteria:
* Type 1 or Type 2 diabetes
* Diabetes duration of \> 1 year
* Age: 18 to 75 years
* Symptomatic neuropathy
* Abnormal amplitude, latency or conduction velocity in at least one motor nerve (Tibial or Peroneal) or in the Sural Nerve
* A measurable Sural Nerve conduction velocity
* Stable glycemic control in the last 3 months, HbA1C \< 11%
* MDNS score \> 7
* Stable dose of analgesic medications, if any, in the month prior enrollment
Exclusion Criteria:
* Previous treatment with TENS or other electrotherapy
* Motor or Sensitive nerve conduction velocity \< 30 non recordable/evocable
* Unstable glycemic control during last 3 months
* Pregnancy
* Implanted pacemaker or defibrillator or neurostimulator
* Cancer diagnosed in the last 5 years
* Psychological or psychiatric disorders that in the Investigator's opinion may interfere with patient's compliance to study procedures
* Active foot ulcer and/or major lower limb amputation
* Diabetic mononeuropathy
* Severe peripheral artery disease (Leriche Fontaine scale grade 3 and 4)
* Ankle-brachial index (ABI) \< 0.7
* Uremic neuropathy or end-stage renal disease
* Toxic neuropathies
* Severe hepatic disease
* Alcohol consumption ≥ 40 g/day or 30 units/week
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01628627
Study Brief:
Protocol Section:
NCT01628627