- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568470
Can the Phoenix Sign be Elicited With D5W
April 30, 2026 updated by: Stephen Barrett, US Neuropathy Centers
Elicitation of the Phoenix Sign With Non-guided Subcutaneous D5W Infiltration
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
- To determine the prevalence of subclinical EHL weakness in a general clinical population
- To measure the time course of strength changes following D5W infiltration
- To identify potential predictive factors for positive response to treatment
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Marietta, Georgia, United States, 30067
- US Neuropathy Centers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- subjects must have a weakness of dorsiflexion and specifically of the Extensor Hallucis Longus muscle
- drop foot
Exclusion Criteria:
- Trypanaphobia
- allergy to D5W
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Infiltration of D5W
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.
|
There is no other intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in motor strength of dorsiflexion of the anterior and lateral compartments of the lower extremity
Time Frame: From enrollment to end of their treatment at 1 day
|
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
Time Frame: From enrollment to the end of the day
|
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
Time Frame: Enrollment to end of clinic vist in 1 hour
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen L Barrett, DPM MBA, US Neuropathy Centers LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 10, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
January 15, 2027
Study Registration Dates
First Submitted
April 5, 2026
First Submitted That Met QC Criteria
April 30, 2026
First Posted (Actual)
May 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USNC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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