New drug could save limbs without surgery

NCT ID NCT05372718

Recruiting now Disease control Sponsor: Supergene, LLC Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called Fortelyzin, which is injected directly into blood clots to dissolve them, in people with acute limb ischemia (sudden loss of blood flow to a limb). The goal is to see if it can prevent amputation as well as or better than standard surgery. About 170 adults with moderate to severe limb ischemia will be randomly assigned to receive the drug or undergo surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Fortelyzin (recombinant non-immunogenic staphylokinase)
What this could lead to: If successful, this could offer a non-surgical option to restore blood flow and prevent limb amputation in people with acute limb ischemia.
What could go wrong: This is still being tested in 170 people, so results may not apply to everyone. The drug could cause bleeding or fail to dissolve the clot, requiring surgery anyway.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

limb ischemia thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE LIMB ISCHEMIA

Contacts and locations

Locations

Kaliningrad Regional Clinical Hospital
RECRUITING

Kaliningrad, 236016, Russia
Kazan City Hospital No. 7
RECRUITING

Kazan', 420103, Russia
Kursk city emergency hospital
RECRUITING

Kursk, Kursl Region, 305035, Russia
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
RECRUITING

Moscow, 125284, Russia
S.S. Yudin City clinical hospital
RECRUITING

Moscow, 115446, Russia
Sergiyev Posad Regional Clinical Hospital
RECRUITING

Sergiyev Posad, Moscow Oblast, 141301, Russia
Ufa Emergency City Hospital
RECRUITING

Ufa, 450092, Russia
Volgograd City Clinical Hospital of Emergency #25
RECRUITING

Volgograd, 400138, Russia

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