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

NCT00658957 | Terminated Phase 2

• 1 other identifier: INN-TOP-002
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who remain free of signs and symptoms of infection until the end of the study

  Up to 3 months

Secondary Outcomes (5)

• Time (days) to complete wound closure

  Actual time

• Time (days) to presence of ≥ 1 of the signs and symptoms of infection

  Actual time

• Absolute and percent decrease in total wound surface area

  End of Study

• Pathogen burden in patients who discontinue because of infection

  Throughout study period

• Treatment emergent Adverse Events

  Throughout study period

Study Arms (2)

A

EXPERIMENTAL

Daily standard wound care and topical application of the gentamicin-collagen sponge twice weekly

Drug: gentamicin-collagen sponge

B

PLACEBO COMPARATOR

Daily standard wound care and topical application of the placebo sponge twice weekly

Drug: placebo collagen sponge

Interventions

gentamicin-collagen sponge DRUG

5 × 5 cm sponge

Also known as: Collatamp G

A

placebo collagen sponge DRUG

5 × 5 cm sponge

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Chesapeake Foot and Ankle Center

Pasadena, Maryland, 21122, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

US (1)