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

Sponsor:	Innocoll Technologies
Collaborator:	Premier Research Group plc
Information provided by:	Innocoll Technologies
ClinicalTrials.gov Identifier:	NCT00658957

Purpose

The purpose of this study is to determine the safety and efficacy of the Collatamp G 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.

Condition	Intervention	Phase
Diabetic Foot Ulcer	Drug: gentamicin-collagen sponge Drug: placebo collagen sponge	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Prevention of Infection Using a Topical Gentamicin-Collagen Sponge (Collatamp G) in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

Drug Information available for: Gentamicins

U.S. FDA Resources

Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	49
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Daily standard wound care and topical application of the gentamicin-collagen sponge twice weekly	Drug: gentamicin-collagen sponge 5 × 5 cm sponge containing 70 mg Type I bovine collagen and 50 mg gentamicin sulfate (32.5 mg gentamicin base) (gentamicin sulfate 2 mg/cm2 [equivalent to gentamicin base 1.3 mg/cm2])
B: Placebo Comparator Daily standard wound care and topical application of the placebo sponge twice weekly	Drug: placebo collagen sponge 5 × 5 cm sponge containing 70 mg Type I bovine collagen

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658957

Locations

United States, Maryland
Chesapeake Foot and Ankle Center
Pasadena, Maryland, United States, 21122

Sponsors and Collaborators

Innocoll Technologies

Premier Research Group plc

Investigators

Study Director:

David Prior

Innocoll Technologies

More Information

No publications provided

Responsible Party:	Innocoll Holdings Inc. ( David Prior, Executive Vice President, Scientific Affairs )
Study ID Numbers:	INN-TOP-002
Study First Received:	April 10, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00658957 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:

Diabetes
Foot Ulcer

Additional relevant MeSH terms:

Anti-Infective Agents
Foot Ulcer
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Foot Diseases
Pharmacologic Actions

Diabetic Angiopathies
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Gentamicins
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on November 27, 2009