AzTrials
AzTrials

Diabetic Foot UlcerPhase 1/2REVERSENCT04803708

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

A Phase 1/2 study testing TP-102 in people with Diabetic Foot Ulcer and Pseudomonas Aeruginosa Infection, run by Technophage, SA at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TP-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesIsrael
Study dates
22 Mar 2021to 5 Sep 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • Both cohorts:
  • Type 1 or type 2 diabetes mellitus with glycated hemoglobin (HbA1c) ≤10, 5%
  • Suitable physical and mental health as determined by the investigator based on medical history and general physical examination.
  • Subjects must be medically stable based on clinical laboratory tests, medical history and vital signs. Clinical laboratory tests should be within normal values or not clinically significant, unless directly related to the condition of diabetes.
  • Female subjects must fulfil one of the following criteria:
  • At least 1 year post-menopausal (amenorrhea >12 months prior to screening);
Show all 16Show fewer
  • Surgically sterile (bilateral oophorectomy or hysterectomy);
  • If of childbearing potential, must agree to use a highly effective method of birth control from screening until 14 days after the last administration of IP.
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.
  • Male subjects with a female partner of child-bearing potential or pregnant partner must agree to use a condom from screening until 14 days after the last IP application.
  • ICF signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of, and procedures required for the study and is willing to participate in the study.
  • Part A:
  • Non-infected diabetic foot ulcer perfusion grade 1, depth grade 1 and infection grade 1 according to PEDIS classification.
  • Part B
  • Infected diabetic foot ulcer meeting perfusion grade 1 or 2, depth grade 1 or 2 and infection 2 or 3,except if presence of abscess, fasciitis, osteomyelitis, and septic arthritis, according to PEDIS definition.
  • Infected with at least one bacterial strain susceptible to bacteriophage cocktail assessed from culture.

Who cannot join

  • Both cohorts:
  • Study ulcer less than 2 cm away from other ulcers in case of multiple ulcers.
  • History in the 5 previous years of any cancer requiring systemic chemotherapy or radiation.
  • A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements.
  • Immunocompromised subjects due to illness, organ transplant, or immune suppressive therapies (e.g. oral or parental corticosteroids, methotrexate, immune modulators) 3 months prior to screening. Ad hoc low dose inhaled corticosteroids or topical corticosteroids are not allowed from 2 weeks prior to randomization.
  • Being pregnant or breastfeeding.
Show all 18Show fewer
  • Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP or 5 half-lives, whichever is longer.
  • Subjects that, in the opinion of the Investigator or their treating physician, are dependent of the following therapies for their ulcer treatment:
  • Topical antimicrobial treatment (including isobetadine gel/dressing, silver nitrate dressing, topical antibiotic)
  • Enzymatic, autolytic, maggot debridement
  • Any active wound healing products (e.g., Dermagraft, Apligraf, Regranex, or Tegaderm hydrogel or others.)
  • Physical or cleansing modalities, antiseptics, corticosteroids, growth factors, solutions other than sterile normal saline and ulcer treatments.
  • Part A:
  • Clinically infected ulcers
  • Part B:
  • Suspected or confirmed abscess, fasciitis, osteomyelitis or septic arthritis.
  • Subjects meeting grade 3 or above PEDIS perfusion criteria
  • Planed or anticipated surgery after screening

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Hadassah Medical Center, Ein Kerem

    Jerusalem, 91091

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: A Double-Blind and Randomized Study to Determine the Safety and Tolerability of Multiple Doses of TP-102 in Subjects With Non-Infected and Infected Diabetic Foot Ulcers

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

Read the detailed description

The primary objective of this study is to evaluate the safety of a topical bacteriophage cocktail in the treatment of non infected and infected diabetic foot ulcers with Pseudomonas aeruginosa, Staphylococcus aureus and/or Acinetobacter baumanni. Patients will also be evaluated for bacterial clearance and wound reduction.

Being tested
TP-102
Keywords
Bacteriophage therapy
Medical subject headings
Diabetic Foot, Pseudomonas Infections, Staphylococcal Infections, Acinetobacter Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TP-102Biological

    One mL of IP solution will be applied topically per cm3 of target ulcer. The titer of each bacteriophage in TP 102 is 1x10^9 plaque forming units per milliliter (PFU/mL).

Study groups in NCT04803708
Study groupRoleWhat they receive
Part A- Cohort 1Experimental8 eligible subjects with non-infected DFU will be enrolled (Cohort 1) and receive IP three times weekly (TIW) every other day for up to one week. Of these 8 enrolled subjects, 6 subjects will be randomized to TP-102 and 2 to placebo. Subjects will be followed-up for 7 days.
Receives: Biological: TP-102
Part B- Cohort 2Experimental18 subjects with a DFU with a grade 2 or 3 infection, as per PEDIS classification, and at least one bacterial strain susceptible to bacteriophage cocktail will be included in Cohort 2. Subjects will receive IP TIW, every other day, up to four weeks and will be randomized at a 2:1 randomization rate to either: * TP-102 q.d 3x weekly up to four weeks (n=12) * Placebo q.d. 3x weekly up to four weeks (n=6) Subjects will be followed-up for 7 days.
Receives: Biological: TP-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Incidence and severity of treatment-emergent solicited local and systemic AEs and relationship to IP from first administration until 1 week after end of treatment (EOT) (end of study -EOS)

    Local AEs include erythema/redness, swelling/induration, pain and tenderness Systemic AEs include fatigue, myalgia, fever, headache and gastrointestinal symptoms (nausea, vomiting, diarrhea)

    Measured: 1 week

  2. 2. Incidence and severity of treatment-emergent unsolicited AEs and relationship to IP from first administration until EOS.

    Measured: 1 week

  3. 3. Incidence and severity of treatment-emergent SAEs and relationship to IP from first administration until EOS.

    Measured: 1 week

Secondary outcomes (4)

  1. Proportion of subjects with significant reduction or eradication from baseline in microbiologic data via culture (cfu) at d3, d8, d15, d22, d26 and EOS

    Measured: 35 days

  2. Time (days) to significant reduction or eradication of target bacteria via culture.

    Measured: 35 days

  3. Changes in wound/ulcer healing from to baseline in terms of wound size and depth (cm^3) at EOT.

    Measured: 35 days

  4. Changes in wound/ulcer healing from to baseline in terms of wound complete closure and partial closure (25%, 50% and 75%) at EOT.

    Measured: 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start22 Mar 2021
  3. Primary completion7 Aug 2022
  4. Study completion5 Sep 2022

Resources

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04803708
Sponsor's protocol ID
TP-102_101
Acronym
REVERSE
Status last verified
Oct 2022
First submitted
2 Mar 2021
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nir-Paz R, Onallah H, Dekel M, Gellman YN, Haze A, Ben-Ami R, Braunstein R, Hazan R, Dror D, Oster Y, Cherniak M, Attal F, Barbosa AR, Dordio H, Wagner A, Jones-Dias D, Neves J, Barreto M, Leandro C, Corte-Real S, Garcia M. Randomized double-blind study on safety and tolerability of TP-102 phage cocktail in patients with infected and non-infected diabetic foot ulcers. Med. 2025 May 9;6(5):100565. doi: 10.1016/j.medj.2024.11.018. Epub 2024 Dec 30.

    PubMed 39740667

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TP-102 in people with Diabetic Foot Ulcer and Pseudomonas Aeruginosa Infection, run by Technophage, SA at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. 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: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Incidence and severity of treatment-emergent solicited local and systemic AEs and relationship to IP from first administration until 1 week after end of treatment (EOT) (end of study -EOS) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04803708, which also lists 1 linked publication.

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 4 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in