NCT04695834 Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
| NCT ID | NCT04695834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Peroneal Nerve Entrapment |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2021-04-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The FOOT DROP trial is a prospective, multi-center, randomized controlled trial to assess if decompressive surgery for peroneal nerve entrapment is superior to maximal conservative treatment. Patients with persisting foot drop due to peroneal nerve entrapment will be randomized to either surgery or conservative treatment if foot drop persists 10 +/- 4 weeks after onset of symptoms. Patients will be evaluated through several questionnaires, evolution of muscle strength and several types of gait assessments. Primary endpoint is the difference in distance covered during the six minute walking test between baseline and 9 months after randomization.
Eligibility 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, …).
Contact & Investigator
Tom Theys, M.D.; Ph.D.
PRINCIPAL INVESTIGATOR
Univeristy hospitals of Leuven
Frequently Asked Questions
Who can join the NCT04695834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peroneal Nerve Entrapment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04695834 currently recruiting?
Yes, NCT04695834 is actively recruiting participants. Contact the research team at christopheoosterbos@gmail.com for enrollment information.
Where is the NCT04695834 trial being conducted?
This trial is being conducted at Mechelen, Belgium, Turnhout, Belgium, Wilrijk, Belgium, Hasselt, Belgium and 11 additional locations.
Who is sponsoring the NCT04695834 clinical trial?
NCT04695834 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Tom Theys, M.D.; Ph.D. at Univeristy hospitals of Leuven. The trial plans to enroll 182 participants.