Diabetic FootPhase 1/2PhagoPiedNCT02664740
Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus
A Phase 1/2 study testing Topical anti-Staphylococcus bacteriophage therapy in people with Diabetic Foot and Staphylococcal Infections, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Staphylococcal Infections
- What is being tested?
- Topical anti-Staphylococcus bacteriophage therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Sep 2026to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
Antoine Dauchy, MD, PhD
CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240
Sophie Schuldiner, MD
Hopital européen
Marseille, 13003
Stanislas Rebaudet, MD, PhD, s.rebaudet@hopital-europeen.fr
Stanislad Rebaudet, MD, PhD
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
Jacques Martini, MD
CH de Tourcoing
Tourcoing, 59200
Benoit Gachet, MD, PhD
CH Intercommunal de Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, 94195
Pauline CARAUX-PAZ, MD
About this study
Official title: Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial
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.
Read the detailed description
The secondary objectives of this study are:
- To compare the two study arms in terms of treatment safety and tolerance throughout the study.
- To compare the two study arms in terms of further changes in wound healing at weeks 2, 4, 6, 8, 10, 12.
- To describe the changes in the resistance and virulence of S. aureus (if present in the wound) from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe in the two study arms the antibiotic resistance status of other bacteria isolated from wounds at week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe in the two study arms changes in wound microbiota from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe the production of anti-phage antibodies during the topical treatment: baseline and week 4, at modification of the first-line treatment or new antibiotic prescription (if any), and at week 12.
- Creation of a biobank for future ancillary studies (including, but not limited to, cytokine levels and cellular immune responses): days 0 and week 4, as well as week 12.
- Conditions
- Diabetic Foot, Staphylococcal Infections
- Being tested
- Topical anti-Staphylococcus bacteriophage therapy, Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy
- Keywords
- Phage Therapy
- Medical subject headings
- Diabetic Foot, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anti-Staphylococcus bacteriophage therapyDrug
Patients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).
Topical placebo corresponding to anti-Staphylococcus bacteriophage therapyDrug
Patients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).
| Study group | Role | What they receive |
|---|---|---|
| Phage therapy | Experimental | Patients randomized to this arm will have phage therapy.
Intervention: Topical anti-Staphylococcus bacteriophage therapy Receives: Drug: Topical anti-Staphylococcus bacteriophage therapy |
| Placebo | Placebo comparator | Patients randomized to this arm will have placebo therapy anologous to that of the experimental arm.
Intervention: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy Receives: Drug: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative reduction in wound surface area (%)
Measured: 12 weeks
Secondary outcomes (69)
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Measured: Day 0, 1 hour after application of experimental dressing
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Measured: Day 7, 1 hour after application of experimental dressing
Immediate Safety
The presence/absence of the following symptoms during each 1 hour observation periods following the application of each experimental wound dressing: local side effects (local rash onset or worsening of local inflammatory signs) and general symptoms (vital signs, fever, rash, arthralgia, gastro-intestinal symptoms...) will be performed.
Measured: Day 14, 1 hour after application of experimental dressing
The number of MedDRA coded Adverse Events per patient
Measured: throughout the study; 12 weeks
The presence/absence of abnormal laboratory results
Measured: throughout the study; 12 weeks
Wound surface area
Measured: 2 weeks
Wound surface area
Measured: 4 weeks
Wound surface area
Measured: 6 weeks
Wound surface area
Measured: 8 weeks
Wound surface area
Measured: 10 weeks
Wound surface area
Measured: 12 weeks
Wound depth
Measured: 2 weeks
Wound depth
Measured: 4 weeks
Wound depth
Measured: 6 weeks
Wound depth
Measured: 8 weeks
Wound depth
Measured: 10 weeks
Wound depth
Measured: 12 weeks
Time to healing
Measured: censored at 12 weeks
The % of completely healed wounds
Measured: 12 weeks
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Measured: 4 weeks
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Classification of Staphylococcus isolates as MSSA or MRSA resistant
MSSA: Methicillin-susceptible Staphylococcus aureus MRSA: Methicillin-resistant Staphylococcus aureus
What is reported is a binary result: isolates are classified as either "MSSA" or "MRSA"
Measured: at week 12 if the wound is still not healed
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Measured: 4 weeks
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Measured: at week 12 if the wound is still not healed
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Measured: week 0
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Measured: week 4
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Measured: at week 12 if the wound is still not healed
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Measured: week 0
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Measured: week 4
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: OTU richness
OTU: Operational Taxonomic Unit
Measured: at week 12 if the wound is still not healed
Wound microbiota: Shannon's Diversity
Measured: week 0
Wound microbiota: Shannon's Diversity
Measured: week 4
Wound microbiota: Shannon's Diversity
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: Shannon's Diversity
Measured: at week 12 if the wound is still not healed
Wound microbiota: Functional richness
Measured: week 0
Wound microbiota: Functional richness
Measured: week 4
Wound microbiota: Functional richness
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: Functional richness
Measured: at week 12 if the wound is still not healed
Wound microbiota: Functional diversity
Measured: week 0
Wound microbiota: Functional diversity
Measured: week 4
Wound microbiota: Functional diversity
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: Functional diversity
Measured: at week 12 if the wound is still not healed
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Measured: week 0
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Measured: week 4
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: the relative abundance of Staphylococcus relative to other bacteria in the wound
Measured: at week 12 if the wound is still not healed
Wound microbiota: the number of Staphylococcus strains in a wound
Measured: week 0
Wound microbiota: the number of Staphylococcus strains in a wound
Measured: week 4
Wound microbiota: the number of Staphylococcus strains in a wound
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: the number of Staphylococcus strains in a wound
Measured: at week 12 if the wound is still not healed
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Measured: week 0
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Measured: week 4
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other bacteria in the wound
Measured: at week 12 if the wound is still not healed
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Measured: week 0
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Measured: week 4
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: the relative abundance of Staphylococcus aureus relative to other Staphylococcus in the wound
Measured: at week 12 if the wound is still not healed
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Measured: week 0
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Measured: week 4
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: ordination scores on each of two principal components extracted from UniFrac distances between all bacterial samples taken during the study
Measured: at week 12 if the wound is still not healed
The presence/absence of anti-phage antibodies in plasma samples
Measured: week 0
The presence/absence of anti-phage antibodies in plasma samples
Measured: week 4
The presence/absence of anti-phage antibodies in plasma samples
Measured: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
The presence/absence of anti-phage antibodies in plasma samples
Measured: at week 12 if the wound is still not healed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Sep 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Phagenix
- Responsible party
- Sponsor
- Investigators
- Albert Sotto, MD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664740
- Sponsor's protocol ID
- PHRC-N/2015/AS-01
- Acronym
- PhagoPied
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2016
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial
- ClinicalTrials.gov ID
- NCT02664740
- Acronym / sponsor ID
- PhagoPied / PHRC-N/2015/AS-01
- Conditions
- Diabetic Foot, Staphylococcal Infections
- Keywords
- Phage Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Phagenix
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The secondary objectives of this study are:
- To compare the two study arms in terms of treatment safety and tolerance throughout the study.
- To compare the two study arms in terms of further changes in wound healing at weeks 2, 4, 6, 8, 10, 12.
- To describe the changes in the resistance and virulence of S. aureus (if present in the wound) from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe in the two study arms the antibiotic resistance status of other bacteria isolated from wounds at week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe in the two study arms changes in wound microbiota from baseline to week 4, at modification of the first-line treatment or new antibiotic prescription (if any) and at week 12 if the wound is still not healed.
- To describe the production of anti-phage antibodies during the topical treatment: baseline and week 4, at modification of the first-line treatment or new antibiotic prescription (if any), and at week 12.
- Creation of a biobank for future ancillary studies (including, but not limited to, cytokine levels and cellular immune responses): days 0 and week 4, as well as week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phage therapy | Experimental | Drug: Topical anti-Staphylococcus bacteriophage therapyPatients randomized to this arm will have phage therapy. Intervention: Topical anti-Staphylococcus bacteriophage therapy |
| Placebo | Placebo comparator | Drug: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapyPatients randomized to this arm will have placebo therapy anologous to that of the experimental arm. Intervention: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical anti-Staphylococcus bacteriophage therapyPatients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds). | Drug | Phage therapy |
| Topical placebo corresponding to anti-Staphylococcus bacteriophage therapyPatients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds). | Drug | Placebo |
Primary outcome
The relative reduction in wound surface area (%)
Time frame: 12 weeks
69 secondary outcomes
Immediate Safety
Time frame: Day 0, 1 hour after application of experimental dressing
Immediate Safety
Time frame: Day 7, 1 hour after application of experimental dressing
Immediate Safety
Time frame: Day 14, 1 hour after application of experimental dressing
The number of MedDRA coded Adverse Events per patient
Time frame: throughout the study; 12 weeks
The presence/absence of abnormal laboratory results
Time frame: throughout the study; 12 weeks
Wound surface area
Time frame: 2 weeks
Wound surface area
Time frame: 4 weeks
Wound surface area
Time frame: 6 weeks
Wound surface area
Time frame: 8 weeks
Wound surface area
Time frame: 10 weeks
Wound surface area
Time frame: 12 weeks
Wound depth
Time frame: 2 weeks
Wound depth
Time frame: 4 weeks
Wound depth
Time frame: 6 weeks
Wound depth
Time frame: 8 weeks
Wound depth
Time frame: 10 weeks
Wound depth
Time frame: 12 weeks
Time to healing
Time frame: censored at 12 weeks
The % of completely healed wounds
Time frame: 12 weeks
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Time frame: 4 weeks
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Classification of Staphylococcus isolates as MSSA or MRSA resistant
Time frame: at week 12 if the wound is still not healed
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time frame: 4 weeks
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Classification of Staphylococcus isolates according to clonal complexes (virulence classification)
Time frame: at week 12 if the wound is still not healed
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time frame: week 0
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time frame: week 4
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Presence/absence of non-Staphylococcus aureus bacteria that are antibiotic-resistant
Time frame: at week 12 if the wound is still not healed
Wound microbiota: OTU richness
Time frame: week 0
Wound microbiota: OTU richness
Time frame: week 4
Wound microbiota: OTU richness
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: OTU richness
Time frame: at week 12 if the wound is still not healed
Wound microbiota: Shannon's Diversity
Time frame: week 0
Wound microbiota: Shannon's Diversity
Time frame: week 4
Wound microbiota: Shannon's Diversity
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Wound microbiota: Shannon's Diversity
Time frame: at week 12 if the wound is still not healed
Wound microbiota: Functional richness
Time frame: week 0
Wound microbiota: Functional richness
Time frame: week 4
Wound microbiota: Functional richness
Time frame: at modification of the first-line treatment or new antibiotic prescription (if any; most likey at 14 days and before 12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Sotto, MD, PhD study director
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical anti-Staphylococcus bacteriophage therapy in people with Diabetic Foot and Staphylococcal Infections, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Sotto, MD, PhD (+33.(0)6.09.56.66.55, albert.sotto@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative reduction in wound surface area (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.