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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01162993
Eligibility Criteria:
Inclusion Criteria:
* Moderate-to-severe PDP in the lower limbs
* The pain intended to treat has been present for more than 12 months
* Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories:
* Amitriptylin or an other tricyclic antidepressant and/or
* Pregabalin (Lyrica®) or Gabapentin (Neurontin®) and/or
* Duloxetine (Cymbalta®) and/or
* Tramadol or strong opioids Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Starting dosage was based on individual patient characteristics. Each drug was tried for at least 3 weeks and dose was raised once, if possible. By insufficient pain relief and/or unacceptable side-effects, the drug treatment was stopped. Patients reached a steady state in medication use and it is not allowed to increase dosage during the study.
* Mean pain intensity during daytime and/or night time should be 5 or higher measured on a numeric rating scale (NRS). Pain during daytime will be scored 3 times per day during for 4 days according to Jensen.
* Patient's age is between 18 and 75 years.
Exclusion Criteria:
* The patient has had neuromodulation therapy during the month before the intake
* Neuropathic pain is most prevalent in the upper limbs (NRS\>3)
* Neuropathy or chronic pain of other origin than diabetes mellitus (NRS\> 3)
* Addiction: drugs, alcohol (\> 5E / day) and/or medication
* Drugs: cocaine, heroine, marihuana.
* Alcohol: wine, beer, liquor (max 5E / day)
* Medication: benzodiazepines.
* Insufficient cooperation from the patient (little motivation, understanding or communication)
* Blood clotting disorder, when using 2 or more different kinds of anti coagulation
* Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to \> prednisolone 10 mg, immunodepressive, etc.)
* Peripheral vascular disease without palpable peripheral pulses at both feet (inclusion is possible if pulses are absent, but ankle brachial index is between 0.7 and 1.2 in both feet)
* Active foot ulceration
* Life expectancy \< 1 year
* Pacemaker
* Local infection or other skin disorders at site of incision
* Psychiatric problems potentially interfering with cooperation in the study
* Pregnancy
* Severe cardiac or pulmonary failure (\> NYHA classification II)
* Unstable blood glucose control (change in HbA1c\>1,0% in three months prior to inclusion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01162993
Study Brief:
Protocol Section:
NCT01162993