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

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ClinicalTrials.gov Identifier: NCT02036528
Recruitment Status : Terminated
First Posted : January 15, 2014
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
Royer Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: Gentamicin Topical Gel Drug: Ciprofloxacin Drug: Doxycycline Phase 1 Phase 2

Detailed Description:

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 demonstrated.

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 bed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: AppliGel-G with oral Ciprofloxacin and Doxycycline
AppliGel-G (Gentamicin Topical Gel) in conjunction with oral Ciprofloxacin and Doxycycline
Drug: Gentamicin Topical Gel
Drug: Ciprofloxacin
Drug: Doxycycline
Active Comparator: Oral Ciprofloxacin and Doxycycline only
Ciprofloxacin and Doxycycline
Drug: Ciprofloxacin
Drug: Doxycycline

Primary Outcome Measures :
  1. Complete wound clearing of infection [ Time Frame: 28 days ]
    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

Secondary Outcome Measures :
  1. Incidence of infection cleared [ Time Frame: 28 days ]
    Incidence of infection cleared at Day 14

  2. DFU Volume % Change [ Time Frame: 28 days ]
    percent change in DFU volume, measured weekly and compared to baseline

  3. DFU Area % Change [ Time Frame: 28 days ]
    percent change in DFU area, measured weekly and compared to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 wound
  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 chemotherapy.
  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 entry.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036528

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United States, District of Columbia
Georgetown University Hospital Center
Washington, District of Columbia, United States, 20007
United States, Florida
GF Professional Research, Corp.
Miami Lakes, Florida, United States, 33016
Florida Medical Center & Research, Inc.
Miami, Florida, United States, 33142
United States, Georgia
Advanced Foot and Ankle Institute of Georgia LLC
Smyrna, Georgia, United States, 30080
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Michigan
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States, 48334
United States, Utah
Utah Valley Medical Center
Provo, Utah, United States, 84604
Sponsors and Collaborators
Royer Biomedical, Inc.
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Responsible Party: Royer Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02036528    
Other Study ID Numbers: CP-RBM-2011-001 DFU
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Royer Biomedical, Inc.:
Foot Ulcer
Diabetic Foot
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors