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New drug could save limbs without surgery

NCT ID NCT05372718

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Oct 06, 2026 · Updated 3 times

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

170 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women aged 18 and older; * Diagnosis of I-II b degree of ALI; * Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after: * women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); * men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility); * Availability of signed and dated informed consent of the patient to participate in the study. Exclusion Criteria: * Extensive bleeding at present; * Intracranial (including subarachnoid) hemorrhage at present; * Recent gastrointestinal bleeding (within 10 days); * Major surgery or major trauma within the previous 3 months, recent traumatic brain injury; * Systolic blood pressure above 180 mm Hg or diastolic blood pressure above 110 mm Hg or the need for intravenous drugs to lower blood pressure to these limits; * Pregnancy, lactation; * Known hypersensitivity to Fortelyzin®; * Platelet count less than 100,000/µL

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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

    Kaliningrad, 236016, Russia

  • Kazan City Hospital No. 7

    Kazan', 420103, Russia

  • Kursk city emergency hospital

    Kursk, Kursl Region, 305035, Russia

  • S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

    Moscow, 125284, Russia

  • S.S. Yudin City clinical hospital

    Moscow, 115446, Russia

  • Sergiyev Posad Regional Clinical Hospital

    Sergiyev Posad, Moscow Oblast, 141301, Russia

  • Ufa Emergency City Hospital

    Ufa, 450092, Russia

  • Volgograd City Clinical Hospital of Emergency #25

    Volgograd, 400138, Russia

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