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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Royer Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
Royer Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02036528
First received: January 10, 2014
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Diabetic Foot Ulcers
Drug: Gentamicin Topical Gel
Drug: Ciprofloxacin
Drug: Doxycycline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royer Biomedical, Inc.:

Primary Outcome Measures:
  • Complete wound clearing of infection [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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:
  • Incidence of infection cleared [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Incidence of infection cleared at Day 14

  • DFU Volume % Change [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    percent change in DFU volume, measured weekly and compared to baseline

  • DFU Area % Change [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    percent change in DFU area, measured weekly and compared to baseline


Estimated Enrollment: 86
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036528

Contacts
Contact: Tatiana Bizikova, RNDr. tbizikova@royerbiomedical.com

Locations
United States, District of Columbia
Georgetown University Hospital Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Elizabeth Benkert    202-444-2000      
Principal Investigator: John Steinberg, Dr.         
United States, Florida
Florida Medical Center & Research, Inc. Recruiting
Miami, Florida, United States, 33142
Contact: Iridalia Gonzalez    786-378-8200      
Principal Investigator: Ramon Berenguer, MD         
GF Professional Research, Corp. Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Yalily Perez    305-821-1535      
Principal Investigator: Gary Keller, DPM         
United States, Georgia
Advanced Foot and Ankle Institute of Georgia LLC Recruiting
Smyrna, Georgia, United States, 30080
Contact: Felicia Thomas    678-679-3300      
Principal Investigator: Fui Dawson, DPM         
United States, Maryland
Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Flossine Brown, BS    410-554-2000      
Principal Investigator: John Senatore, DPM         
United States, Michigan
Detroit Clinical Research Center, PC Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Candice Shallal    248-716-7010      
Principal Investigator: Marshall Solomon, DPM         
United States, Utah
Utah Valley Medical Center Recruiting
Provo, Utah, United States, 84604
Contact: Annette Gwilliam, RN    801-357-8156      
Principal Investigator: Marc Robins, Dr.         
Sponsors and Collaborators
Royer Biomedical, Inc.
  More Information

No publications provided

Responsible Party: Royer Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02036528     History of Changes
Other Study ID Numbers: CP-RBM-2011-001 DFU
Study First Received: January 10, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Royer Biomedical, Inc.:
Foot Ulcer
Diabetic Foot
Gentamicins
infection

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Ciprofloxacin
Doxycycline
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 28, 2014