Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
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
1 other identifier
interventional
9
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedMay 14, 2015
May 1, 2015
11 months
January 10, 2014
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete wound clearing of infection
Proportion of subjects with foot ulcer infection completely cleared at or by 28 days of AppliGel-G treatment compared to proportion of subjects with foot ulcer infection completely cleared at or by 28 days of control treatment
28 days
Secondary Outcomes (3)
Incidence of infection cleared
28 days
DFU Volume % Change
28 days
DFU Area % Change
28 days
Study Arms (2)
AppliGel-G with oral Ciprofloxacin and Doxycycline
EXPERIMENTALAppliGel-G (Gentamicin Topical Gel) in conjunction with oral Ciprofloxacin and Doxycycline
Oral Ciprofloxacin and Doxycycline only
ACTIVE COMPARATORCiprofloxacin and Doxycycline
Interventions
Eligibility Criteria
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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Georgetown University Hospital Center
Washington D.C., District of Columbia, 20007, United States
Florida Medical Center & Research, Inc.
Miami, Florida, 33142, United States
GF Professional Research, Corp.
Miami Lakes, Florida, 33016, United States
Advanced Foot and Ankle Institute of Georgia LLC
Smyrna, Georgia, 30080, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, 48334, United States
Utah Valley Medical Center
Provo, Utah, 84604, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 15, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Last Updated
May 14, 2015
Record last verified: 2015-05