Diabetic Foot UlcersPhase 1/2NCT02036528
Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
A Phase 1/2 study testing Gentamicin Topical Gel, Ciprofloxacin and Doxycycline in people with Diabetic Foot Ulcers, run by Royer Biomedical, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Gentamicin Topical Gel, Ciprofloxacin and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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..
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Union Memorial Hospital
Baltimore, Maryland, 21218
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, 48334
Florida Medical Center & Research, Inc.
Miami, Florida, 33142
GF Professional Research, Corp.
Miami Lakes, Florida, 33016
Utah Valley Medical Center
Provo, Utah, 84604
Advanced Foot and Ankle Institute of Georgia LLC
Smyrna, Georgia, 30080
Georgetown University Hospital Center
Washington D.C., District of Columbia, 20007
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Gentamicin Topical Gel, Ciprofloxacin, Doxycycline
- Keywords
- Foot Ulcer, Diabetic Foot, Gentamicins, infection
- Medical subject headings
- Diabetic Foot, Foot Ulcer, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin Topical GelDrug
CiprofloxacinDrug
DoxycyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| AppliGel-G with oral Ciprofloxacin and Doxycycline | Experimental | AppliGel-G (Gentamicin Topical Gel) in conjunction with oral Ciprofloxacin and Doxycycline Receives: Drug: Gentamicin Topical Gel; Drug: Ciprofloxacin; Drug: Doxycycline |
| Oral Ciprofloxacin and Doxycycline only | Active comparator | Ciprofloxacin and Doxycycline Receives: Drug: Ciprofloxacin; Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (3)
Incidence of infection cleared
Incidence of infection cleared at Day 14
Measured: 28 days
DFU Volume % Change
percent change in DFU volume, measured weekly and compared to baseline
Measured: 28 days
DFU Area % Change
percent change in DFU area, measured weekly and compared to baseline
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royer Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036528
- Sponsor's protocol ID
- CP-RBM-2011-001 DFU
- Status last verified
- May 2015
- First submitted
- 10 Jan 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02036528
- Acronym / sponsor ID
- CP-RBM-2011-001 DFU
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Foot Ulcer, Diabetic Foot, Gentamicins, infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Royer Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AppliGel-G with oral Ciprofloxacin and Doxycycline | Experimental | Drug: Gentamicin Topical Gel, Drug: Ciprofloxacin, Drug: DoxycyclineAppliGel-G (Gentamicin Topical Gel) in conjunction with oral Ciprofloxacin and Doxycycline |
| Oral Ciprofloxacin and Doxycycline only | Active comparator | Drug: Ciprofloxacin, Drug: DoxycyclineCiprofloxacin and Doxycycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicin Topical Gel | Drug | AppliGel-G with oral Ciprofloxacin and Doxycycline |
| Ciprofloxacin | Drug | AppliGel-G with oral Ciprofloxacin and Doxycycline, Oral Ciprofloxacin and Doxycycline only |
| Doxycycline | Drug | AppliGel-G with oral Ciprofloxacin and Doxycycline, Oral Ciprofloxacin and Doxycycline only |
Primary outcome
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
3 secondary outcomes
Incidence of infection cleared
Time frame: 28 days
DFU Volume % Change
Time frame: 28 days
DFU Area % Change
Time frame: 28 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gentamicin Topical Gel, Ciprofloxacin and Doxycycline in people with Diabetic Foot Ulcers, run by Royer Biomedical, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound clearing of infection (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.