Surgery vs. conservative treatment for foot drop caused by peroneal nerve entrapment
Official title: A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
Run by Universitaire Ziekenhuizen KU Leuven · NCT04695834 · Data updated 2026-11-12
This study is testing whether surgery or physical therapy works better for people with ongoing foot drop caused by nerve issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 182 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 18 sites (Mechelen, Antwerpen and 17 other locations) |
| Status | Recruiting |
| Started | April 28, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | July 1, 2024 |
| Trial ID | NCT04695834 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with documented peroneal nerve entrapment and persistent foot drop after 10 ± 4 weeks of symptom onset.
✕Probably not a fit
Patients with foot drop due to other causes, such as traumatic injuries or compressive masses, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The FOOT DROP trial is a multi-center, randomized controlled trial designed to compare the effectiveness of decompressive surgery against maximal conservative treatment for patients with persistent foot drop due to peroneal nerve entrapment. Participants will be randomized to receive either surgical intervention or conservative management focusing on physiotherapy if their symptoms persist for 10 ± 4 weeks. The study will evaluate outcomes through various questionnaires, muscle strength assessments, and gait evaluations over a period of 18 months, with the primary endpoint being the distance covered in a six-minute walking test at 9 months post-randomization. This trial aims to provide robust evidence on the best treatment approach for this condition.
Why it matters
Potential benefit: If successful, this trial could provide clear guidance on whether surgical intervention is more effective than conservative treatment for improving mobility in patients with foot drop.
How similar studies have gone: This is the first prospective randomized controlled trial on this topic, as previous literature consists mainly of biased retrospective case series.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent to participate in the study must be obtained from the subject or proxy / legal representative prior to initiation of any study-mandated procedure * EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot drop (MRC-score ≤ 3) * Imaging (ultrasound/MRI) performed to exclude a compressive mass * Age ≥ 18 years Exclusion Criteria: * Subjects with posttraumatic or iatrogenic peroneal nerve injury * Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst, tumour) * Peroneal nerve entrapment at other sites than the fibular head * Patients with mental or physical problems that incapacitate them to participate in a physiotherapy program * Psychiatric illness * Pregnancy * Planned (e)migration within 1 year after randomization to another country * Subjects with previous foot drop * Permanently bedridden subjects * Subjects with neurological or musculoskeletal history which could impact foot drop assessment and/or gait analysis (e.g. polyneuropathy, hereditary neuropathy with pressure palsies, critical illness polyneuropathy, previous stroke, ankle surgery, …).
Where it's running
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AZ Groeninge, department of neurosurgery
Kortrijk, West-Vlaanderen, Belgium Recruiting -
ULB Erasme, department of neurosurgery
Brussels, Belgium Recruiting -
Ziekenhuis Oost-Limburg, department of neurosurgery
Genk, Belgium Recruiting -
University Hospitals Of Leuven, department of neurosurgery
Leuven, Belgium Recruiting -
CHU de Liège, department of neurosurgery
Liège, Belgium Recruiting -
Leids Universitair Medisch Centrum, department of neurosurgery
Leiden, Netherlands Recruiting
Show 12 more locations
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AZ Sint-Maarten
Mechelen, Antwerpen, Belgium Not yet recruiting -
AZ Turnhout
Turnhout, Antwerpen, Belgium Not yet recruiting -
Sint Augustinus
Wilrijk, Antwerpen, Belgium Not yet recruiting -
Jessa Ziekenhuis
Hasselt, Limburg, Belgium Not yet recruiting -
AZ Vesalius
Tongeren, Limburg, Belgium Not yet recruiting -
AZ Alma
Eeklo, Oost-Vlaanderen, Belgium Not yet recruiting -
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium Not yet recruiting -
AZ Sint-Jan
Bruges, West-Vlaanderen, Belgium Not yet recruiting -
AZ Damiaan
Ostend, West-Vlaanderen, Belgium Not yet recruiting -
AZ Delta
Roeselare, West-Vlaanderen, Belgium Not yet recruiting -
Universitaire Ziekenhuizen Antwerpen
Antwerp, Belgium Not yet recruiting -
UZ Brussel
Brussels, Belgium Not yet recruiting
Study contacts
- Principal investigator: Tom Theys, M.D.; Ph.D. — Univeristy hospitals of Leuven
- Study coordinator: Christophe Oosterbos, M.D.
- Email: christopheoosterbos@gmail.com
- Phone: +3216344290
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.