Diabetic Foot Infection Clinical Trial
Official title:
A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 in Patients With Moderate to Severe Diabetic Foot Infection (DFI)
This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.
This is a randomized, double-blind, placebo-controlled, multi-center study that will be
conducted in two parts. In Part I, patients will be enrolled into escalating dose cohorts
(150, 375, or 600 µg/mL) (N=16/cohort) at a ratio of 3:1 (Active to Placebo). In Part II,
patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose
demonstrated in Part I.
Patients with diabetes mellitus and a foot infection with an Infectious Disease Society of
America (IDSA) infection severity rating of moderate or severe will be eligible for the
trial. Both inpatients and outpatients are eligible if they meet all inclusion/exclusion
criteria, however all enrolled patients must remain in-hospital for the first 24 hours after
initial dosing. Patients with a need for surgical therapy (e.g., incision and drainage or
removal of necrotic tissue) beyond standard bedside wound debridement should not be enrolled.
Patients will be randomized to receive either topical application of MBN-101 or topical
application of vehicle, applied directly to the target site, 3 times per week, for a minimum
of 14 days and up to a maximum of 21 days. The determination to stop topical antibiotic
therapy will be at the discretion of the principal investigator, and should be based on the
resolution of findings of infection. All patients will also receive systemic antibiotic
treatment based on the protocol defined algorithm. Systemic antibiotic therapy should
continue until, but not beyond, the resolution of findings of infection, as outlined in the
2012 IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot
infections,
;
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 |
NCT05948592 -
Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
|
Phase 2 | |
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 |
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 |
NCT01594762 -
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
|
Phase 3 | |
Completed |
NCT01590758 -
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 |