G63.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with diabetes mellitus type 2 and stable levels of HbA1c (deviation < 1% during the last 6 months), clinically assured diabetic peripheral neuropathy and pathologic results in nerve conduction studies of tibial nerve and sural nerve will be included.
Exclusion criteria
Exclusion criteria: Other diseases than diabetes that may cause peripheral neuropathy; History of epilepsy; Coagulopathy or use of anticoagulants with bleeding time > 3 min, prothrombin time 50 sec; Bacterial infection or other skin diseases at the lower extremities; Bone fracture of the lower extremities during the last three months; Alcohol, opiat, analgetic, or drug abuse; Psychiatric illnesses other than mild depression; Incapacity of following the study instructions ;(severe language disturbances, serious cognitive deficits, lack of time); Pregnant or breast-feeding women; Current participation in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-post comparison of the sensory sural nerve action potential amplitude (SNAP) before and 4 weeks after the treatment (week 0 and 14) by nerve conduction studies | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-post comparison of sensory sural nerve conduction velocity, motor tibial nerve action potential amplitude and motor tibial nerve conduction velocity by nerve conduction studies; pre-post comparison of Neuropathic Deficit Score (NDS) and Neuropathic Symptom Score (NSS) as well as of subjective complaints by visual analogue scales (VAS) before and 4 weeks after the treatment (week 0 and week 14) | — |
Countries
Germany
Contacts
HanseMerkur Zentrum für Traditionelle Chinesische Medizin am Universitätsklinikum Hamburg-Eppendorf