Clinical trial NCT02036528: Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetic Foot Ulcers
Keywords: Foot Ulcer
Diabetic Foot
Gentamicins
infection
Lead sponsor: Royer Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Complete wound clearing of infection
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of infection cleared
timeFrame: 28 days
measure: DFU Volume % Change
timeFrame: 28 days
measure: DFU Area % Change
timeFrame: 28 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital Center
state: District of Columbia
city: Miami Lakes
country: United States
facility: GF Professional Research, Corp.
state: Florida
city: Miami
country: United States
facility: Florida Medical Center & Research, Inc.
state: Florida
city: Smyrna
country: United States
facility: Advanced Foot and Ankle Institute of Georgia LLC
state: Georgia
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center, PC
state: Michigan
city: Provo
country: United States
facility: Utah Valley Medical Center
state: Utah
Study officials:
References: