Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers

Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Age Range:18 - Any
Start Date:January 2014
Contact:Tatiana Bizikova, RNDr.

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A Phase I/II, Open Label, Controlled Study to Evaluate the Safety and Efficacy of AppliGel-G [Gentamicin Sulfate Topical Gel] for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers in Patients With Type 1 and Type 2 Diabetes

The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus
oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to
moderately infected foot ulcers in diabetic patients.

Infection of a diabetic foot ulcer (DFU) is a serious and common complication of diabetes
and is among the most common diabetes-related cause of hospitalization and the leading cause
of diabetes-associated lower limb amputation. The effectiveness of various systemic
antibiotics, particularly the fluoroquinolones, in treating infected DFUs has been

An alternative or adjunct to systemic antibiotic treatment of infected DFU's is topical
antibiotic treatment. Topical treatment would have the advantages of avoiding systemic
adverse effects, providing increased target site concentration, and allowing the use of
antibiotics not approved for systemic treatment.

AppliGel-G is a topically applied hydrogel formulation of gentamicin sulfate (GMS). Once in
place the product remains in contact with the wound bed and releases Gentamicin to the wound

Inclusion Criteria:

1. Subject is 18 years of age or older

2. Subject has a mild to moderately infected (IDSA Mild or Moderate/ PEDIS Grade 2 or 3)
diabetic foot ulcer and without a previous history of partial foot amputation.

3. Subject has Diabetes Mellitus (type 1 or type 2).

4. Wound area measurement between 1-25 cm2 and does not exceed 25 cm2.

5. Subject is in general good health in the opinion of the investigator as determined by
medical history, vital signs and a physical examination.

6. Female subjects must have a negative urine pregnancy test at screening and be willing
and able to use a medically acceptable method of birth control or declare that they
are abstaining from sexual intercourse, from the screening visit through the study
termination visit or be surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined
as women with menstruation cessation for 12 consecutive months prior to signing of
the informed consent form.

7. Subject has either no renal failure or only mild renal failure (i.e.: glomerular
filtration rate (GFR) must be above 60 mL/min/1.73m2)

8. Subject is willing and committed to comply with the research protocol and complete
all outcome measures.

9. Subject is able to self-consent.

10. Subject is able to speak and read English..

Exclusion Criteria:

1. Subject is non-diabetic

2. Subject's foot lesion(s) are of etiology other than diabetic neuropathy

3. DFU is PEDIS Infection Grade 1 or 4

4. Infected DFU measures >25 cm2

5. The wound involves bone, tendon or joint damage not due to infection

6. Wound with sinus tracts

7. HbA1c>11%

8. Subject with skin disorders unrelated to the ulcer that are presented adjacent to the

9. Clinically significant arterial vascular disease based on Skin Perfusion Pressure
System (SensiLase) measurement of skin perfusion pressure (SPP) of <30 mm Hg.

10. Subject is receiving, or has received within one month prior to enrollment any
treatment known to impair wound healing, including but not limited to:
corticosteroids, immuno-suppressive drugs, cytotoxic agents, radiation therapy and

11. Known history of a significant medical disorder, which in the investigator's judgment
contraindicates the subject's participation.

12. Has active malignant disease of any kind. A subject, who has had a malignant disease
in the past, was treated and is currently disease-free, may be considered for study

13. Subjects who present with significant metabolic co morbidity that would preclude
wound healing such as end stage renal failure, dialysis or severe liver dysfunction.

14. Known hypersensitivity and/or allergy to gentamicin or the study oral antibiotics or
related drugs.

15. Drug or alcohol abuse (by history). 16 Subjects participating in any other trials in
regards to the diabetic foot ulcer or antibiotic therapy.

17 History of myasthenia gravis 18 Any condition or use of prescribed medication in which
participation in this study would impact the safety of the individual participant.
We found this trial at
286 Westward Drive
Miami, Florida 33142
Miami, FL
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Baltimore, Maryland
Baltimore, MD
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Farmington Hills, Michigan 48334
Farmington Hills, MI
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Miami Lakes, Florida 33016
Miami Lakes, FL
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Provo, Utah 84604
Provo, UT
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Smyrna, GA
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Washington, District of Columbia 20007
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