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Clinical Trials/DRKS00021151
DRKS00021151
Recruiting
未知

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

BG Trauma center Ludwigshafen, Department for Plastic and Reconstructive Surgery0 sites20 target enrollmentJune 21, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
G63.2
Sponsor
BG Trauma center Ludwigshafen, Department for Plastic and Reconstructive Surgery
Enrollment
20
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 21, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
BG Trauma center Ludwigshafen, Department for Plastic and Reconstructive Surgery

Eligibility Criteria

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

Exclusion Criteria

  • Hba1c \>8\.5, uncontrolled diabetes, neurological disorders as potential confounders, Ankle\-Brachial Index \<0,75

Outcomes

Primary Outcomes

Not specified

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