Pilotstudy - targeted peripheral nerve decompression for treatment of painful diabetic neuropathy

Not Applicable

Recruiting

• Conditions: G63.2; Diabetic polyneuropathy

• Registration Number: DRKS00021151
• Lead Sponsor: BG Trauma center Ludwigshafen, Department for Plastic and Reconstructive Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Diabetes mellitus Typ 2 and Typ 1
- blood glucose = 126 mg/dl
- HbA1c = 6,5%
• diabetic sensimotor neuropathy of both lower extremities
- Neuropathie-Defizit-Score 6-8 Points or
- Neuropathie-Defizit-Score 3-5 Points + Neuropathie-Symptom-Score 4-6 Points
• bilateral tharapy-refractory pain (VAS >5)
• clinical or neuroradiological signs of bilateral nerve compression (nervus tibialis and/or Nervus peroneus
communis)

Exclusion Criteria

Hba1c >8.5, uncontrolled diabetes, neurological disorders as potential confounders, Ankle-Brachial Index <0,75

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain intensity (1-10) in the area supplied by the decompressed nerve

Secondary Outcome Measures

Name	Time	Method
2PD, monofilament threshold, target muscle force, diabetic ulcer formation, nerve conduction velocity