#1 Clinical Trials Search in Europe

Study on the Safety and Effectiveness of TP-102 for Treating Diabetic Foot Infections in Patients

2 1 1

What is this study about?

This clinical trial is focused on studying a condition known as diabetic foot infection, which can occur in people with diabetes. This infection often involves bacteria such as Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus. The study is testing a new treatment called TP-102, which is a special mixture of bacteriophages. Bacteriophages are tiny viruses that can target and destroy specific bacteria. The treatment is applied directly to the wound on the foot. Another treatment being used in the study is a solution called sodium chloride, which is commonly used in medical settings.

The purpose of the study is to evaluate the safety and effectiveness of the TP-102 treatment in helping to heal diabetic foot infections. Participants in the study will receive either the TP-102 treatment or a placebo, in addition to the standard care they would normally receive for their condition. The study will last for about a month, during which the effects of the treatment on the infection and wound healing will be closely monitored.

Throughout the study, researchers will observe how well the treatment works in reducing the size of the wound and improving the overall condition of the infection. They will also keep track of any side effects that may occur. The goal is to determine if TP-102 can be a safe and effective option for treating diabetic foot infections, potentially offering a new way to help patients with this challenging condition.

1 beginning of the trial

Upon joining the study, the patient will receive a detailed explanation of the trial procedures and objectives. The patient will be asked to sign an informed consent form, confirming understanding and willingness to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure the patient meets the study criteria.

3 treatment phase

The patient will receive the study medication, TP-102, which is applied topically to the wound. The frequency and duration of application will be determined by the study protocol and communicated to the patient by the study team.

The patient will also continue to receive the standard of care for diabetic foot infections, which may include wound cleaning and dressing changes.

4 monitoring and follow-up

Throughout the trial, the patient will have regular follow-up visits to monitor the wound healing process and any potential side effects. These visits will include physical examinations and possibly additional laboratory tests.

The patient will be asked to report any changes in health or new symptoms to the study team immediately.

5 end of treatment

At the end of the treatment period, the patient will have a final assessment to evaluate the effectiveness of the treatment and any changes in the condition of the wound.

The patient will be informed about the results of the study and any further steps if necessary.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of Diabetes Mellitus (type I or II).
  • Must have a glycosylated hemoglobin (HbA1c) value of 12.0% or less. HbA1c is a blood test that shows average blood sugar levels over the past 2-3 months.
  • The foot infection must meet the following criteria:
    • Present for at least 3 weeks.
    • Located below the ankle and is a full-thickness skin ulcer.
    • The wound area, after cleaning, is 20.0 cm² or smaller.
    • Classified as Mild to Moderate infection according to specific guidelines.
    • Has a certain level of blood flow and depth as determined by medical guidelines.
  • Must have a diabetic foot infection with at least one of the following bacteria: Pseudomonas aeruginosa, Staphylococcus aureus, or Acinetobacter baumannii, which can be treated with the study medication.
  • Must be in suitable physical and mental health as determined by the study doctor.
  • If a woman can become pregnant, she must have a negative pregnancy test at the start of the study.
  • Women who can become pregnant must agree to use one of the following forms of birth control while taking the study medication and for four weeks after:
    • Combined hormonal birth control (oral, vaginal, or skin patch).
    • Progestogen-only hormonal birth control (oral, injectable, or implantable).
    • Intrauterine device (IUD) or hormone-releasing system (IUS).
    • Bilateral tubal occlusion (surgical procedure to block fallopian tubes).
    • Partner has had a vasectomy (surgical procedure for male sterilization).
    • Sexual abstinence (not having sex).
  • Must voluntarily sign an Informed Consent Form before any study-related procedures, indicating understanding and willingness to participate in the study.

Who Cannot Join the Study?

  • Patients with a history of allergic reactions to the study medication or its ingredients cannot participate.
  • Individuals who have received another investigational drug within the last 30 days are excluded.
  • Patients with severe liver or kidney disease are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Individuals with a history of alcohol or drug abuse in the past year are excluded.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe are not eligible.
  • Individuals who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Inbctkfj Mhosjvib Wny Ijc Wnxklyr Cjvudgn Lublin Poland
Awqd Ph Sew z ojxy Lodz Poland
Pojas Kdefjdw Lublzojp Rjf Smr z oi o Legionowo Poland
Aptinkirxmwiik Poznan Poland
Plkvvou Sdz z owdj Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.07.2025

Trial locations

Investigated drugs:

TP-102 is a type of treatment known as bacteriophage therapy. This therapy uses viruses that specifically target and destroy bacteria. In this clinical trial, TP-102 is applied directly to the skin to help treat infections in the feet of people with diabetes. The goal is to see if TP-102 can safely and effectively help heal these infections by reducing the number of harmful bacteria, which can improve the overall condition of the wound.

Investigated diseases:

Diabetic Foot Ulcers – Diabetic foot ulcers are open sores or wounds that occur in approximately 15% of patients with diabetes, usually located on the bottom of the foot. They develop due to a combination of factors, including poor circulation, neuropathy, and high blood sugar levels, which impair the body’s ability to heal. The progression of these ulcers can lead to infection, especially when bacteria such as Acinetobacter baumannii, Pseudomonas aeruginosa, or Staphylococcus aureus are involved. As the ulcer worsens, it can penetrate deeper into the skin, affecting underlying tissues and potentially leading to more severe complications. The healing process is often slow and can be complicated by the presence of infection, requiring careful management to prevent further deterioration.

Trial ID:
2023-507716-13-00
Protocol code:
TP-102_102
NCT ID:
NCT05948592
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on the Safety and Effectiveness of Contezolid Acefosamil, Contezolid, and Linezolid for Adults with Moderate or Severe Diabetic Foot Infections

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia Estonia France Greece +9