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

Stopped early · Phase 1/Phase 2

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID: NCT02036528
Run by: Royer Biomedical, Inc.
People needed: 9
Starts: 2014-01-01
Last updated by the study team: 2015-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is 18 years of age or older
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.
Subject has Diabetes Mellitus (type 1 or type 2).
Wound area measurement between 1-25 cm2 and does not exceed 25 cm2.
Subject is in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
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.
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)
Subject is willing and committed to comply with the research protocol and complete all outcome measures.
Subject is able to self-consent.
Subject is able to speak and read English..

You may not qualify if…

Subject is non-diabetic
Subject's foot lesion(s) are of etiology other than diabetic neuropathy
DFU is PEDIS Infection Grade 1 or 4
Infected DFU measures >25 cm2
The wound involves bone, tendon or joint damage not due to infection
Wound with sinus tracts
HbA1c>11%
Subject with skin disorders unrelated to the ulcer that are presented adjacent to the wound
Clinically significant arterial vascular disease based on Skin Perfusion Pressure System (SensiLase) measurement of skin perfusion pressure (SPP) of <30 mm Hg.
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 chemotherapy.
Known history of a significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
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 entry.
Subjects who present with significant metabolic co morbidity that would preclude wound healing such as end stage renal failure, dialysis or severe liver dysfunction.
Known hypersensitivity and/or allergy to gentamicin or the study oral antibiotics or related drugs.
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.

Where it is running

Georgetown University Hospital Center — Washington D.C., District of Columbia, United States
Florida Medical Center & Research, Inc. — Miami, Florida, United States
GF Professional Research, Corp. — Miami Lakes, Florida, United States
Advanced Foot and Ankle Institute of Georgia LLC — Smyrna, Georgia, United States
Union Memorial Hospital — Baltimore, Maryland, United States
Detroit Clinical Research Center, PC — Farmington Hills, Michigan, United States
Utah Valley Medical Center — Provo, Utah, United States

Full record on ClinicalTrials.gov

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