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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AppliGel-G with oral Ciprofloxacin and Doxycycline | Experimental | AppliGel-G (Gentamicin Topical Gel) in conjunction with oral Ciprofloxacin and Doxycycline |
|
| Oral Ciprofloxacin and Doxycycline only | Active Comparator | Ciprofloxacin and Doxycycline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin Topical Gel | Drug |
| ||
| Ciprofloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection cleared | Incidence of infection cleared at Day 14 | 28 days |
| DFU Volume % Change | percent change in DFU volume, measured weekly and compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital Center | Washington D.C. | District of Columbia | 20007 | United States | ||
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| Drug |
|
| Doxycycline | Drug |
|
| 28 days |
| DFU Area % Change | percent change in DFU area, measured weekly and compared to baseline | 28 days |
| 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 |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D016523 | Foot Ulcer |
| D007239 | Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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