Diabetic Foot InfectionPhase 2REVERSE2NCT05948592
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
A Phase 2 study testing TP-102 in people with Diabetic Foot Infection, run by Technophage, SA at 10 sites in 2 countries.
Trial summary
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- TP-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 8 Nov 2023to 19 Dec 2025
- Phase
- Phase 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
- Aged ≥18 years old;
- Established diagnosis of Diabetes Mellitus (type I or II);
- Glycosylated hemoglobin (HbA1c) value < 12.0%;
- Designated foot infection meets the following criteria:
- Present for at least 3 weeks;
- Below-ankle, full-thickness, cutaneous ulcer;
Show all 14Show fewer
- Wound area (after debridement, if applicable) 1 to 20.0 cm2;
- PEDIS infection grade 2 or 3;
- PEDIS perfusion grade 1 or 2;
- PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
- Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
- Patients of suitable physical and mental health as determined by the Investigator on the basis of medical history and general physical examination;
- Patients of childbearing potential must have a negative serum pregnancy test at screening;
- ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.
Who cannot join
- Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
- Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
- Patient which, in the opinion of the investigator, may not comply with study related procedures;
- Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
- Being pregnant or breastfeeding;
- 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;
- A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
- Participants with hypersensitivity to any component of investigational products.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
India8 sites
MV Hospital for Diabetes Pvt. Ltd
Chennai, 600013
GSVM Medical College
Kanpur
Crescent Hospital & Heart Centre
Nagpur, 440012
Shree Siddhi Vinayak Hospital
Nashik, 422002
Jupiter Hospital & Research Center
Vadodara, 390012
Parikh Multispeciality Healthcare Pvt. Ltd
Vadodara, 390020
Aman Hospital & Research Centre
Vadodara, 390021
Yalamanchi Hospitals & Research Centers Pvt. Ltd
Vijayawada, 520002
United States2 sites
Clemente Clinical Research
Los Angeles, California, 90033
Tranquil Clinical Research
Webster, Texas, 77598
About this study
Official title: A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).
Read the detailed description
This is a Phase 2b, double-blinded, randomised, placebo-controlled multicenter study to determine the safety and efficacy of TP-102, in patients with diabetic foot infection.
Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.
Patients will be randomised to receive TP-102 or placebo, in a 1:1 ratio. Patients will be treated with 1 (one) mL of IP/ Placebo solution applied topically per cm3 of target ulcer. Patients will be treated with a total of 12 treatments in 28 days (+3 days) with at least one day of interval in between the days of treatment (no consecutive days of treatment are allowed) and a maximum of 3 (three) days without treatment.
The titre of each bacteriophage in TP-102 is 1x109 (>1x108 and < 1x1010) plaque forming units per milliliter (PFU/mL).
Assessments for efficacy and safety will include concomitant medications and AEs, local tolerability, clinical laboratory tests, vital signs, physical examination, wound biopsy/swab to determine the presence, speciation and TP-102 sensitivity of bacteria and target ulcer assessment.
- Conditions
- Diabetic Foot Infection
- Being tested
- TP-102, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-102Biological
Patients randomised to TP-102 will receive 1 (one) mL of IP solution, applied topically per cm3 of target ulcer. The titre of each bacteriophage in TP-102 is 1x109 PFU/mL (>1x108 PFU/mL and <1x1010 PFU/mL). All patients randomised to TP-102 will receive the same concentration per mL. TP-102 will be applied to the target ulcer using a syringe without a needle. The volume of TP-102 to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
PlaceboOther
Patients randomised to placebo, the volume calculated to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
| Study group | Role | What they receive |
|---|---|---|
| TP-102 | Experimental | Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine. Receives: Biological: TP-102 |
| Placebo | Placebo comparator | Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Number and percentage of treatment emergent adverse events (TEAEs)
See above
Measured: From baseline to EOT, aproximately 12 weeks
2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
See above
Measured: From baseline to EOT, , aproximately 12 weeks
3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
Measured: Week 4
Secondary outcomes (4)
1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo
Measured: From baseline to EOT, , aproximately 12 weeks
2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC
Measured: Baseline to EOT, , aproximately 12 weeks
3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;
Measured: EOT, , aproximately 12 weeks
4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT;
Measured: EOT, , aproximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start8 Nov 2023
- Primary completion30 Oct 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technophage, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Responsible party
- Sponsor
- Investigators
- Sachin Arsule, Principal investigator, Shree Siddhi Vinayal HospitalYalamanchi Rao, Principal investigator, Yalamanchi Hospitals & Research Centers Pvt. LtdSenthil Kumar, Principal investigator, MV Hospital for Diabetes Pvt. LtdAman Khanna, Principal investigator, Aman Hospital & Research CentreMohammad Qureshi, Principal investigator, Crescent Hospital & Heart CentreParikh Niranjan, Principal investigator, Parikh Multispeciality Healthcare Pvt. LtdSanjay Kala, Principal investigator, GSVM Medical CollegeVikas Matai, Principal investigator, Jupiter Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948592
- Sponsor's protocol ID
- TP-102_102
- Acronym
- REVERSE2
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI
- ClinicalTrials.gov ID
- NCT05948592
- Acronym / sponsor ID
- REVERSE2 / TP-102_102
- Conditions
- Diabetic Foot Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Technophage, SAIndustry (pharma, biotech, devices)
- Collaborators
- VectorB2B
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 17 Jul 2023 (actual)
- 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.
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).
Detailed description
This is a Phase 2b, double-blinded, randomised, placebo-controlled multicenter study to determine the safety and efficacy of TP-102, in patients with diabetic foot infection.
Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.
Patients will be randomised to receive TP-102 or placebo, in a 1:1 ratio. Patients will be treated with 1 (one) mL of IP/ Placebo solution applied topically per cm3 of target ulcer. Patients will be treated with a total of 12 treatments in 28 days (+3 days) with at least one day of interval in between the days of treatment (no consecutive days of treatment are allowed) and a maximum of 3 (three) days without treatment.
The titre of each bacteriophage in TP-102 is 1x109 (>1x108 and < 1x1010) plaque forming units per milliliter (PFU/mL).
Assessments for efficacy and safety will include concomitant medications and AEs, local tolerability, clinical laboratory tests, vital signs, physical examination, wound biopsy/swab to determine the presence, speciation and TP-102 sensitivity of bacteria and target ulcer assessment.
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 |
|---|---|---|
| TP-102 | Experimental | Biological: TP-102Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine. |
| Placebo | Placebo comparator | Other: PlaceboPatients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥18 years old;
- Established diagnosis of Diabetes Mellitus (type I or II);
- Glycosylated hemoglobin (HbA1c) value < 12.0%;
- Designated foot infection meets the following criteria:
- Present for at least 3 weeks;
Key exclusion criteria (8 listed)
- Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
- Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
- Patient which, in the opinion of the investigator, may not comply with study related procedures;
- Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
- Being pregnant or breastfeeding;
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 |
|---|---|---|
| TP-102Patients randomised to TP-102 will receive 1 (one) mL of IP solution, applied topically per cm3 of target ulcer. The titre of each bacteriophage in TP-102 is 1x109 PFU/mL (>1x108 PFU/mL and <1x1010 PFU/mL). All patients randomised to TP-102 will receive the same concentration per mL. TP-102 will be applied to the target ulcer using a syringe without a needle. The volume of TP-102 to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette). | Biological | TP-102 |
| PlaceboPatients randomised to placebo, the volume calculated to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette). | Other | Placebo |
Primary outcome
1. Number and percentage of treatment emergent adverse events (TEAEs)
Time frame: From baseline to EOT, aproximately 12 weeks
See above
2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
Time frame: From baseline to EOT, , aproximately 12 weeks
See above
3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
Time frame: Week 4
4 secondary outcomes
1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo
Time frame: From baseline to EOT, , aproximately 12 weeks
2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC
Time frame: Baseline to EOT, , aproximately 12 weeks
3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;
Time frame: EOT, , aproximately 12 weeks
4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT;
Time frame: EOT, , aproximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Infection
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
RecruitingPhase 3
Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)
Diabetic Foot Infection
Not yet recruitingObservational study
18F-FDG PET/CT for Diagnosis of Diabetic Foot Osteomyelitis
Diabetic Foot Infections
Active, not recruiting
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer
Diabetic Foot Ulcer, Diabetic Foot Infection
RecruitingPhase 2
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
Diabetic Foot Ulcers (DFUs)
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. This study is not recruiting at the moment.
Sachin Arsule principal investigator
Shree Siddhi Vinayal Hospital
Yalamanchi Rao principal investigator
Yalamanchi Hospitals & Research Centers Pvt. Ltd
Senthil Kumar principal investigator
MV Hospital for Diabetes Pvt. Ltd
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP-102 in people with Diabetic Foot Infection, run by Technophage, SA at 10 sites in 2 countries.
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 14 inclusion and 8 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India, United States. 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 phase mean?
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. Number and percentage of treatment emergent adverse events (TEAEs) (time frame: From baseline to EOT, aproximately 12 weeks). 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?
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 22 Dec 2025.