Virus cocktail takes on stubborn diabetic foot infections
NCT ID NCT02664740
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CH Intercommunal de Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, 94195, France
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CH de Tourcoing
Tourcoing, 59200, France
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CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240, France
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CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059, France
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CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000, France
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Hopital européen
Marseille, 13003, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a model predict the right dose of rifampicin for bone infections?
- Sound waves and nanoparticles join forces to heal diabetic foot wounds
- Smartphone app could let diabetic foot ulcer patients skip clinic visits for wound checks
- Placenta power: could donor cells heal diabetic foot wounds?
- Pig liver scaffold may speed healing of stubborn diabetic wounds