Drop FootNCT07568470
Can the Phoenix Sign be Elicited With D5W
A study testing Infiltration of D5W in people with Drop Foot, run by US Neuropathy Centers at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drop Foot
- What is being tested?
- Infiltration of D5W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- subjects must have a weakness of dorsiflexion and specifically of the Extensor Hallucis Longus muscle
- drop foot
Who cannot join
- Trypanaphobia
- allergy to D5W
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Drop Foot
- Being tested
- Infiltration of D5W
- Keywords
- Drop Foot, Nerve Blocks
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration of D5WDrug
There is no other intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Infiltration of D5W |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Enrollment to end of clinic vist in 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start10 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drop FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Neuropathy Centers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Barrett, US Neuropathy Centers
- Investigators
- Stephen L Barrett, DPM MBA, Principal investigator, US Neuropathy Centers LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568470
- Sponsor's protocol ID
- USNC
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elicitation of the Phoenix Sign With Non-guided Subcutaneous D5W Infiltration
- ClinicalTrials.gov ID
- NCT07568470
- Acronym / sponsor ID
- USNC
- Conditions
- Drop Foot
- Keywords
- Drop Foot, Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- US Neuropathy CentersUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Infiltration of D5W | Experimental | Drug: Infiltration of D5W3 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- subjects must have a weakness of dorsiflexion and specifically of the Extensor Hallucis Longus muscle
- drop foot
Key exclusion criteria (2 listed)
- Trypanaphobia
- allergy to D5W
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infiltration of D5WThere is no other intervention. | Drug | Infiltration of D5W |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen L Barrett, DPM MBA principal investigator
US Neuropathy Centers LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration of D5W in people with Drop Foot, run by US Neuropathy Centers at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.