Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus

NCT02664740 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PHRC-N/2015/AS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.

Conditions

Diabetic Foot; Staphylococcal Infections

Keywords

Phage Therapy

Outcome Measures

Primary Outcomes (1)

• The relative reduction in wound surface area (%)

  12 weeks

Secondary Outcomes (69)

• Immediate Safety

  Day 0, 1 hour after application of experimental dressing

• Immediate Safety

  Day 7, 1 hour after application of experimental dressing

• Immediate Safety

  Day 14, 1 hour after application of experimental dressing

• The number of MedDRA coded Adverse Events per patient

  throughout the study; 12 weeks

• The presence/absence of abnormal laboratory results

  throughout the study; 12 weeks

Study Arms (2)

Phage therapy

EXPERIMENTAL

Patients randomized to this arm will have phage therapy. Intervention: Topical anti-Staphylococcus bacteriophage therapy

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

Drug: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy

Interventions

Topical anti-Staphylococcus bacteriophage therapy DRUG

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).

Phage therapy

Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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,

You may not qualify if:

• 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 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
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Phagenix: collaborator

Study Sites (6)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

Location

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

Le Grau-du-Roi, 30240, France

Location

Hopital européen

Marseille, 13003, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

CH de Tourcoing

Tourcoing, 59200, France

Location

CH Intercommunal de Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, 94195, France

Location

MeSH Terms

Conditions

Diabetic Foot; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Albert Sotto, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Central Study Contacts

Albert Sotto, MD, PhD

CONTACT

+33.(0)6.09.56.66.55; albert.sotto@chu-nimes.fr

Christophe Masseguin, PhD

CONTACT

+33.(0)4.66.68.68.36; christophe.masseguin@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 27, 2016
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (6)