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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

NCT04803708

Diabetic Foot Ulcer Pseudomonas Aeruginosa Infection Staphylococcus Aureus Infection +1 more

COMPLETED PHASE1/PHASE2

Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

NCT05948592

Diabetic Foot Infection

COMPLETED PHASE2

Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes

NCT04289948

Diabetes Diabetic Foot Diabetic Foot Infection

WITHDRAWN PHASE1/PHASE2

The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

NCT00659646

Diabetic Foot Ulcer

COMPLETED PHASE2

Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

NCT00764361

Diabetic Foot Ulcer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The secondary objectives of this study are:

A. To compare the two study arms in terms of treatment safety and tolerance throughout the study.

B. To compare the two study arms in terms of further changes in wound healing at weeks 2, 4, 6, 8, 10, 12.

C. 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.

D. 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.

E. 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.

F. 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.

G. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Staphylococcal Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phage therapy

Patients randomized to this arm will have phage therapy.

Intervention: Topical anti-Staphylococcus bacteriophage therapy

Group Type EXPERIMENTAL

Topical anti-Staphylococcus bacteriophage therapy

Intervention Type 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).

Placebo

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

Group Type PLACEBO_COMPARATOR

Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topical anti-Staphylococcus bacteriophage therapy

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).

Intervention Type DRUG

Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 target wound is classified as P (1 or 2), E (1-30 cm\^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification

* 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 target wound is classified as P (1 or 2), E (1-30 cm\^2), D (2), I (2) and S (1 or 2) according to the PEDIS classification
* The patient's wound is mono-infected with Staphylococcus aureus (MRSA or MSSA)

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

* 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 who have received antibiotics within the 7 days preceding inclusion
* Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis\*
* Patients with diabetic foot wounds associated with critical limb ischemia according to P = grade 3 in the PEDIS classification
* Patients whose wound is infected by a pathogen other than S. aureus (includes multi-infections) according to bacteriological sampling performed at the pre-inclusion visit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No