Diabetic patients with a moderate infection of a lower extremity skin ulcer MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Interventions
Product Name: gentamicin collagen sponge
Pharmaceutical Form: Medicated sponge
INN or Proposed INN: Gentamicin Sulfate
CAS Number: 1404-41-0
Concentration unit: mg milligram(s)
Concentration type: ran
Sponsors
Innocoll Technologies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Is a man or woman aged = 18 and = 80 years. 2. Has diabetes mellitus, according to the American Diabetes Association criteria. 3. Has a single infected skin ulcer below the knee, defined as “moderate” by the Infectious Disease Society of America (IDSA) Guidelines for whom, in the Investigator’s opinion, intravenous (IV) or oral antimicrobial therapy is appropriate (IDSA Guidelines, CID 204;39:885-910). Moderate infection severity guideline: Infection in a patient who is systemically well and metabolically stable characterized by the presence of = 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth, or induration) that has = 1 of the following characteristics: cellulitis extending 2 cm, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone. 4. Has had an x-ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis must receive appropriate surgical intervention to remove all necrotic and infected bone and otherwise meet enrollment criteria before being enrolled in the study. 5. Meets the following laboratory criteria: • Hemoglobin (Hb) > 10 g/dL. • White blood cells (WBC) = 4000 cells/mm3 and/or absolute neutrophil count (ANC) = 1500 cells/mm3. • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) within 3x the upper limit of normal (ULN). • Hemoglobin A1C (HbA1C) 1.3 may be included if they have either a transcutaneous oxygen pressure or a toe pressure = 40 mm Hg on limb with ulcer.) 7. If female, is nonpregnant (negative pregnancy test results at the Baseline/Randomization Visit) and nonlactating. 8. If female, is either not of childbearing potential (defined as postmenopausal for = 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing 1 of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the study: • Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit. • Total abstinence from sexual intercourse (= 1 complete menstrual cycle before the Baseline/Randomization Visit). • Intrauterine device (IUD). • Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream). 9. Willing to return to the study facility for the Final Study Visit. 10. Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or levofloxacin or drugs in the same class, or any of the test article or reference product components. 2. Has a known hypersensitivity to bovine collagen. 3. Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study. 4. Has a target ulcer with a wound size > 10 × 10 cm. 5. Has gangrenous tissue of the affected limb that cannot be removed with a single debridement. 6. Has wound known to contain isolates resistant to levofloxacin. 7. Has a wound associated with prosthetic material or device. 8. Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 [Day 1]). 9. If severely immunocompromised, may be excluded at the discretion of the Investigator. 10. Has a history of alcohol or substance abuse in the past 12 months. 11. Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or peritoneal) or has a history of kidney transplant. 12. Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator. 13. Has a history of epilepsy 14. Has a history of tendon disorders related to fluoroquinolone administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of the Collatamp G® Topical Gentamicin-Collagen Sponge (gentamicin sponge) in combination with antimicrobial therapy compared to antimicrobial therapy alone on patients’ clinical outcome in the treatment of moderately infected skin ulcers;Secondary Objective: • To determine the effect of the gentamicin sponge in combination with antimicrobial therapy compared to antimicrobial therapy alone on eradication of wound pathogens • To assess the effect of the gentamicin sponge in combination with antimicrobial therapy compared to antimicrobial therapy alone on absolute and percent decrease of total wound surface area • To assess the safety and tolerability of the gentamicin sponge in combination with antimicrobial therapy • To assess the systemic exposure to gentamicin following the administration of the gentamicin sponge by measuring serum gentamicin concentrations in a subset of patients at various time points after applying the gentamicin sponge;Primary end point(s): Percent of patients with a clinical outcome of “clinical cure” in each treatment group at Visit 3 (Day 7) Clinical cure is defined as: The resolution of all signs and symptoms of infection(purulence or evidence of inflammation) tht were present at enrollment and the patient requires no further antimicrobial therapy or surgical intervention to treat the infection. | — |
Countries
United Kingdom
Outcome results
None listed