drugset / Trial / NCT04270019

Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

NCT04270019

Phase 1/2 Withdrawn Nova Scotia Health Authority
RandomizedSingle-groupQuadruple-blindTreatment

Summary

PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels. Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.

Timeline

Start
2020-06-26
Primary completion
2023-09-15
Completion
2023-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject polyethylene glycol Other / unclassified 50 % Other