Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01500668

Enrollment

Registered

2011-12-28

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catocholamine Induced Finger Necrosis

Keywords

Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin

Brief summary

Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called blue toe syndrome) is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.

Interventions

DRUGBotox

Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.

DRUGPlacebo

Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients treated with vasoactive drugs (amines) and have finger/toe necrosis

Exclusion criteria

* Sensitivity to drug (Botox) ingredients. * Active local limb infection * ICU admission due to botulism * Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS * Age lower than 18

Design outcomes

Primary

Measure	Time frame	Description
index of Toe and Finger Ischemia (iTFI)	three months after drug administration	Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Secondary

Measure	Time frame	Description
Amputation	Three months after drug administration	Amputations performed - fingers, toe and limb - height and number of amputations
Patients survival	Three months after drug administration	Survival

Countries

Israel

Contacts

Primary ContactAmir Herman, MD, PhD

amirherm@gmail.com972-52-2655026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026