Clinical study
PhagoPied
Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
| Status | Conflicting status |
|---|---|
| Type | Trial |
| Countries | France |
| Conditions studied | Diabetic Foot; Staphylococcal Infections |
| Study years | 2026 (estimated)–2028 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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.
Study description
The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.
Study registrations
| ClinicalTrials.gov | NCT02664740 |
|---|---|
| CTIS | 2022-500541-24-00 |
Recorded study locations (6)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Recorded site status: Not separately listed. Study location source ↗
CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, France
Recorded site status: Not separately listed. Study location source ↗
Hopital européen
Marseille, France
Recorded site status: Not separately listed. Study location source ↗
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, France
Recorded site status: Not separately listed. Study location source ↗
CH de Tourcoing
Tourcoing, France
Recorded site status: Not separately listed. Study location source ↗
CH Intercommunal de Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, France
Recorded site status: Not separately listed. Study location source ↗
Related programs(1)
CHU Nîmes / PhagoPied multicenter study
Intake unconfirmed
Recorded program–study link. Website
Notes from the source review
- CTIS2022-500541-24-00 shows Authorised,recruiting France, start2024-07-02; CTgov says not yet recruiting. Status conflict needs trial-site confirmation.
- ClinicalTrials.gov not yet recruiting as of2026-03-20 conflicts with current CTIS display. Contact French trial site before presenting an open place.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct02664740 |
|---|