Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Virus cocktail takes on stubborn diabetic foot infections

NCT ID NCT02664740

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a special virus mixture (phage therapy) to standard wound care can shrink diabetic foot ulcers infected with staph bacteria more than standard care alone. About 60 adults with diabetes and a foot ulcer that has lasted over 2 weeks will take part. The treatment is applied directly to the wound, and healing is measured after 12 weeks.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Participant pre-inclusion criteria: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is at least 18 years old * The patient has type 1 or type 2 diabetes * The patient is hospitalized/consulting in a participating centre * The patient has a wound below the ankle that has be evolving for \>2 weeks * The patient has a neuropathic foot wound, classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification, * without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \> 50 mm Hg or toe systolic arterial pressure \> 30 mm Hg or TcpO2 \> 30 mm Hg ) * with a surface area ≥ 0,5 cm2 * With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis (normal radiography\*) * Females of childbearing potential or Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration * Negative pregnancy test must be obtained before starting any experimental drug * Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months) Participant final inclusion criteria: * The patient has a neuropathic foot wound: * Classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification, * without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \> 50 mm Hg or toe systolic arterial pressure \> 30 mm Hg or TcpO2 \> 30 mm Hg ) * with a surface area ≥ 0,5 cm2 * With IWGDF/IDSA grade 2 or 3 infection without osteomyelitis * The patient's wound is monoinfected by methicillin-resistant or susceptible S. aureus (MSSA or MRSA ), or infected by MSSA or MRSA and other bacteria (a total of 3 bacteria when accounting for MSSA or MRSA) * The Phagogram of the patient demonstrated that the strains are susceptible to at least one phage(PP1493 and/or PP1815). Participant pre-exclusion criteria: * The patient is participating in, or has participated in over the past three months, another trial * The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, or is an adult under guardianship * It is impossible to correctly inform the patient * The patient refuses to sign the consent * The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug * Women/Men refusing to use an effective contraception during and1 month after the last administration of study drug Participant final exclusion criteria: * The patient refuses to participate to the study * The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug * Women/Men refusing to use an effective contraception during and1 month after the last administration of study drug * Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis\* * Patient is not infected by S. aureus or infected by more than 3 bacteria even if the culture isolates a S. aureus.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetic foot are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Intercommunal de Villeneuve-Saint-Georges

    Villeneuve-Saint-Georges, 94195, France

  • CH de Tourcoing

    Tourcoing, 59200, France

  • CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

    Le Grau-du-Roi, 30240, France

  • CHRU de Toulouse - Hôpital de Rangueil

    Toulouse, 31059, France

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000, France

  • Hopital européen

    Marseille, 13003, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.