A Randomized, Controlled, Open-Label Study to Investigate the Safety and Efficacyof a Topical Gentamicin-Collagen Sponge (Collatamp® G) in Combination WithAntimicrobial Therapy Compared to Antimicrobial Therapy Alone in DiabeticPatients with Moderately Infected Lower Extremity Skin Ulcers - N/A
- Conditions
- Diabetic patients with a moderate infection of a lower extremity skin ulcerMedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcer
- Registration Number
- EUCTR2008-001376-73-GB
- Lead Sponsor
- Innocoll Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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) < 10%.
6. Has an ankle-brachial index (ABI) = 0.7 and = 1.3. (Note:
Patients with ABI < 0.7 or > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method