Diabetic Foot Infection Clinical Trial
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)).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Recruiting |
NCT05613985 -
PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers
|
N/A | |
| Recruiting |
NCT03964571 -
Human and Bacterial Protease Activity as Prognostic Tool of Foot Infections in Diabetic Patients
|
N/A | |
| Completed |
NCT03230175 -
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
|
Phase 2 | |
| Completed |
NCT05616351 -
Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
|
||
| Recruiting |
NCT04714411 -
Real-World Efficacy and Safety Analysis of Omadacycline for the Treatment of Diabetic Foot Infections and Acute Osteomyelitis
|
||
| Completed |
NCT05243810 -
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers
|
N/A | |
| Recruiting |
NCT05610865 -
Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers
|
Phase 1 | |
| Recruiting |
NCT04450693 -
Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)
|
Phase 3 | |
| Recruiting |
NCT05369052 -
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)
|
Phase 3 | |
| Completed |
NCT02723539 -
A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
|
Phase 1 | |
| Completed |
NCT04440839 -
Implementation of Telemedicine for Patient With Lower Extremity Wounds
|
N/A | |
| Withdrawn |
NCT04289948 -
Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes
|
Phase 1/Phase 2 | |
| Completed |
NCT03495349 -
Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.
|
||
| Completed |
NCT05564728 -
Diabetes Footcare Companion App for Patients and Carers
|
||
| Withdrawn |
NCT03354806 -
Peripheral Analgesia in Painful Diabetic Neuropathy
|
N/A | |
| Completed |
NCT01590758 -
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
|
Phase 3 | |
| Completed |
NCT01594762 -
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
|
Phase 3 | |
| Active, not recruiting |
NCT05174806 -
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
|
Phase 2 | |
| Recruiting |
NCT04141787 -
Ceftriaxone as Home IV for Staph Infections
|
Phase 4 |