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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021151
Enrollment
20
Registered
2021-06-21
Start date
2021-02-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G63.2

Interventions

Group 1: Unilateral lower extremity nerve decompression Group 2: Contralateral lower extremity, non-decompressed

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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 communis)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
pain intensity (1-10) in the area supplied by the decompressed nerve—

Secondary

MeasureTime frame
2PD, monofilament threshold, target muscle force, diabetic ulcer formation, nerve conduction velocity—

Countries

Germany

Contacts

Public ContactSimeon Däschler

BG trauma center Ludwigshafen, Department for Plastic and Reconstructive Surgery

simeonchristian.daeschler@bgu-ludwigshafen.de+49 (6 21) 68 10 8936

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026