NCT07568470

Brief Summary

To determine if the Phoenix sign can be reliably elicited with non-guided subcutaneous infiltration of D5W (5% Dextrose in Water) in patients with subclinical weakness of the extensor hallucis longus (EHL) muscle.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 5, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 5, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Drop Foot, Nerve Blocks

Outcome Measures

Primary Outcomes (3)

  • Changes in motor strength of dorsiflexion of the anterior and lateral compartments of the lower extremity

    Each subject will receive the infiltration and then be assessed for any changes in motor strength at 4 and 10 minutes after the injection.

    From enrollment to end of their treatment at 1 day

  • Presence of absence of increase in motor strength of the lower extremity in dorsiflexion

    Using manual motor testing the strength of the lower extremity in dorsiflexion will be evaluated with a score of 1-5 out of 5.

    From enrollment to the end of the day

  • Number of subjects that have increased dorsiflexion strength after D5W infiltration

    Subjects will be evaluated by manual motor testing of the patient before and after infiltration of D5W on a 1 to 5 out of 5 mother strength grading.

    Enrollment to end of clinic vist in 1 hour

Study Arms (1)

Infiltration of D5W

EXPERIMENTAL

3 cc's of D5W will be infiltrated subcutaneously at the level of the fibular neck to see if there is any improvement in dorsiflexion strength at 4 and 10 minutes post infiltration.

Drug: Infiltration of D5W

Interventions

There is no other intervention.

Infiltration of D5W

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects must have a weakness of dorsiflexion and specifically of the Extensor Hallucis Longus muscle
  • drop foot

You may not qualify if:

  • Trypanaphobia
  • allergy to D5W

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Neuropathy Centers

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Stephen L Barrett, DPM MBA

    US Neuropathy Centers LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: To test the hypothesis that the phoenix sign can be elicited with non-guided subcutaneous infiltration of D5W 20 Clinics/research sites with 30 consecutive patients would then account for 600 patients. Each clinic/researcher will evaluate 30 consecutive patients regardless of what pathology they are presenting to the clinic with, for EHL strength bilaterally. This compilation would then allow for a calculation of how many (what percentage) of them actually had a subclinical weakness. If there is a 10% incidence of subclinical weakness, then 60 patients would be enrolled in the study for evaluation of the effect of non-guided subcutaneous infiltration of D5W. Every patient that has documented weakness based on simple muscle grading of the EHL in this group would then ideally be enrolled into the clinical study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 5, 2026

First Posted

May 5, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations