Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

This study has been terminated.
(Business Decision)
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00658957
First received: April 10, 2008
Last updated: March 22, 2012
Last verified: March 2012

April 10, 2008
March 22, 2012
April 2008
October 2009   (final data collection date for primary outcome measure)
The percentage of patients who remain free of signs and symptoms of infection until the end of the study [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658957 on ClinicalTrials.gov Archive Site
  • Time (days) to complete wound closure [ Time Frame: Actual time ] [ Designated as safety issue: No ]
  • Time (days) to presence of ≥ 1 of the signs and symptoms of infection [ Time Frame: Actual time ] [ Designated as safety issue: Yes ]
  • Absolute and percent decrease in total wound surface area [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Pathogen burden in patients who discontinue because of infection [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
  • Treatment emergent Adverse Events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer
A Phase II, Randomized, Parallel, Double-blind, Placebo-controlled Study to Assess Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers

The purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a physician or podiatrist), compared with placebo sponge combined with standard of care, in preventing infection of diabetic lower extremity skin ulcers.

Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to prevent infection and ultimately prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

In this study, all subjects will be given the necessary supplies and taught how to take care their foot ulcer. Subjects will be randomly assigned to receive either the gentamicin-collagen sponge or a plain collagen sponge. The sponge will be applied into the ulcer twice a week during the treatment period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Diabetic Foot Ulcer
  • Drug: gentamicin-collagen sponge
    5 × 5 cm sponge
    Other Name: Collatamp G
  • Drug: placebo collagen sponge
    5 × 5 cm sponge
  • Experimental: A
    Daily standard wound care and topical application of the gentamicin-collagen sponge twice weekly
    Intervention: Drug: gentamicin-collagen sponge
  • Placebo Comparator: B
    Daily standard wound care and topical application of the placebo sponge twice weekly
    Intervention: Drug: placebo collagen sponge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is a man or woman aged ≥ 18 and ≤ 80 years.
  • Has diabetes mellitus according to the American Diabetes Association criteria.
  • Has a single skin ulcer below the knee, defined as "uninfected" by the Infectious Disease Society of America Guidelines (Wound lacking purulence or any manifestations of inflammation).
  • Has had an x-ray of the affected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
  • 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 the limb with the target ulcer.)
  • Meets certain minimal laboratory criteria.
  • If female, is nonpregnant (negative pregnancy tests at the Baseline/Randomization Visit) and nonlactating.
  • If female, is either not of childbearing potential (defined as postmenopausal for at least 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 (minimum of 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).

  • Willing to return to the study facility for the Posttreatment Evaluation Visit.
  • Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion Criteria:

  • Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or any of the test article or reference product components.
  • Has a known hypersensitivity to bovine collagen.
  • Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
  • Has a target ulcer with a wound size > 5 × 5 cm.
  • Has gangrene or infection of the affected limb.
  • Has a wound associated with prosthetic material or device.
  • Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 [Day 1]).
  • Has documented osteomyelitis.
  • If severely immunocompromised, may be excluded at the discretion of the Investigator.
  • Has a history of alcohol or substance abuse in the past 12 months.
  • Is undergoing dialysis (renal or peritoneal) or has history of kidney transplant.
  • Has history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00658957
INN-TOP-002
No
Innocoll Technologies
Innocoll Technologies
Premier Research Group plc
Study Director: David Prior Innocoll Technologies
Innocoll Technologies
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP